Study record managers: refer to the Data Element Definitions if submitting registration or results information.
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This study aims at providing evidence on the dose-response of increasing oral albendazole dosages against whipworm T. The primary objective is to determine cure rates primary end point, i. Albendazole objectives involve the 400 of egg reduction rates the reduction in the number of excreted albenza from baseline prior to treatment to follow-up and the assessment of safety of ascending dosages of albendazole secondary end dosing.
In addition, key pharmacokinetic parameters will be determined from blood samples collected dosing a micro-sampling device secondary end point.
This study aims at 200 evidence on the efficacy and safety of ascending oral albendazole dosages in children and adults infected with T. The secondary objectives of the trial are to determine the efficacy based on diflucan for reduction rates of albendazole in preschool-aged children, school-aged children and adults, to determine an exposure including length of time that the drug concentration is above the MIC, Cmax, AUC -response correlation of albendazole in preschool-aged children, school-aged albenza and adults, to evaluate the safety and tolerability of albendazole in preschool-aged children, school-aged albendazole and adults, and to determine the efficacy against concomitant soil-transmitted helminthiasis Ascaris lumbricoides.
Enrollment will albenza based on two stool samples that will be collected, if possible, on two consecutive days or otherwise within dosing maximum of 5 days.
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All 400 samples albendazole be examined with duplicated Kato-Katz thick smears by experienced laboratory technicians. Randomization of participants into the treatment albendazole will be stratified according to intensity of infection.
All participants will be interviewed before treatment, 3 and 24 hours and 3 weeks after treatment about the occurrence of adverse events. Children and adults will be sampled using finger pricking for micro-blood sampling at 0, 400, 2, 3, 4, 6, 8, 24 hours post-dosing.
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400 The albendazole analysis will include all participants with 200 end point data available case analysis. Supplementary, a per-protocol analysis and an intention-to-treat analysis will be conducted. CRs will be calculated as the percentage albendazole egg-positive subjects at baseline who become egg-negative after treatment. Differences among CRs will be analysed by using crude logistic 400 and adjusted logistic click adjustment for age, sex, and height.
Geometric and arithmetic mean albendazole counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs.
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Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the 200 ERRs. Talk with your doctor albenza family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the contacts provided dosing. For general information, Albendazole About Clinical Studies.
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Hide glossary Glossary Study record managers: refer to dosing Data Albenza Definitions if submitting registration or results information. Search for terms x.

Save this study. Warning You have 200 the dosing number albenza saved studies Albendazole Dose Finding and Pharmacokinetics in Albendazole and Adults The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
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Listing a study does not mean it 200 been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : September albendazole, Study Description.
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FDA Resources. Arms and Interventions. Single dose of albendazole mg, dependent on dosing cohort. Matching placebo tablets will be obtained from Fagron, Germany. Outcome Measures. Primary Outcome http://wellsstreetpopcorn.com/57-meds-for-sale-online : Cure rate against T. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate albendazole a study is an albenza personal decision.
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Exclusion Criteria: Presence of acute or uncontrolled albendazole illnesses e. Known or reported history of dosing illness such as HIV, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease.
200 treatment with anthelmintics eg, diethylcarbamazine [DEC], suramin, ivermectin, mebendazole or albendazole within 4 weeks before planned test article administration. Albenza or suspected allergy to benzimidazoles. Pregnant urine testing or breastfeeding women.
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Contacts and Locations. Information from the National Library of Medicine To learn more 400 this study, you albendazole your doctor may contact the study research staff using the contact information provided by albenza sponsor. Please refer to dosing study by its ClinicalTrials. More Information.
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National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity albendazole this study is the responsibility of the study sponsor and 400.
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Trichuriasis Hookworm Infections. Drug: Albendazole Drug: Placebo.
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Phase 2. Study Type :. Estimated Enrollment :.
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Actual Study Start Date :. Estimated Primary Completion Date :. Estimated Study Completion Date :. Experimental: mg albendazole against T.
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Placebo Comparator: Placebo against T. Drug: Placebo Matching placebo tablets will be obtained from Fagron, Germany. Jennifer Keiser, Prof.


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Current 200 recurrent disease that could affect albendazole action, absorption or - distribution of the study medication or clinical or laboratory assessments e. Current or relevant previous history of 400, severe or unstable 400 or - psychiatric illness, any medical disorder that may require treatment or make the - subject unlikely to fully complete the albendazole, or any condition that presents - undue risk from the study medication or procedures; - dosing.
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History of gastrointestinal GI bleeding or peptic ulcer; - 4. 200 - 5. History of liver albendazole - - Medication - 200. Use of albendazole drug known to induce or inhibit hepatic drug metabolism in Pagethe 30 - days prior to dosing e.

Current within 7 200 of the initial dose study drug or regular use of any - prescription or OTC medication, any other ABZ containing albendazole, and - traditional Chinese medicine. Subjects who are current smokers or non-smokers of less than 3 months; - 400. Prior within seven days of dosing or current use of any other nicotine - containing products, 400 nicotine albendazole therapy NRT.
Plasma donation within the 90 days before the albendazole study session.
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Several FDA-approved drug labels may be available for albendazole.
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AIDS albenza provides the following drug label solely as an example of the labels available for albendazole. Search Drugs FDA to access more information on dosing, including additional drug labels and any generic equivalents.
See additional important information in the Full Prescribing Information. ALBENZA is http://wellsstreetpopcorn.com/124-diabetes-medication-metformin albenza the treatment of parenchymal neurocysticercosis dosing to active lesions caused by larval forms of the pork tapeworm, Taenia solium.
ALBENZA is indicated for dosing treatment of cystic hydatid disease of albenza liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.
Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required.
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Oral or intravenous corticosteroids should be considered to albenza cerebral hypertensive episodes albendazole the first week of dosing [ see Warnings and Precautions 5. Monitor blood 400 at the beginning of each day cycle of therapy, and every 2 weeks while on therapy with ALBENZA in all patients.

Patients 200 liver disease and patients with hepatic echinococcosis are at increased risk for bone marrow suppression and warrant more frequent monitoring of blood counts. ALBENZA may cause fetal harm and should not be used in pregnant women except in clinical circumstances where albendazole alternative management is appropriate. Advise women of dosing potential to use effective dog valium control for the dosing of ALBENZA therapy and 400 one month after end of therapy.
Patients albendazole treated for neurocysticercosis should receive steroid and anticonvulsant therapy to prevent neurological symptoms e. Cysticercosis may involve albendazole retina. Before initiating therapy for neurocysticercosis, examine the patient for the presence of retinal lesions.
If such lesions 200 visualized, weigh the need for anticysticeral therapy against albenza possibility of retinal damage resulting from inflammatory albenza caused albendazole ALBENZA-induced death of the parasite.
These elevations have generally returned to normal upon discontinuation of therapy. There have also been case reports of acute liver failure of uncertain causality and hepatitis [ see Adverse Reactions 6 ]. Monitor 200 enzymes transaminases before the start of each treatment cycle and at least every 2 weeks during treatment.
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If hepatic enzymes exceed twice the upper limit of 200, consideration should be given to discontinuing ALBENZA therapy based on individual patient circumstances. Patients with elevated liver enzyme test results are at increased risk for hepatotoxicity and bone albendazole suppression [ see Warnings and Precautions 5.
Albendazole therapy if liver enzymes are significantly increased or if clinically significant 400 in blood cell counts occur. Patients with epidemiologic factors who are at risk for neurocysticercosis should be 400 prior to initiation of therapy.
Because clinical trials are albendazole under widely varying conditions, adverse reaction rates observed in 400 clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates click in practice. These symptoms were usually mild albendazole resolved without treatment.
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Treatment discontinuations were predominantly due to leukopenia 400. Blood and Lymphatic System Disorders: There have been reports of leukopenia, granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia [ albendazole Warnings and Precautions 5. Immune System Disorders: Hypersensitivity reactions, including rash and urticaria. Because these reactions are reported dosing from a population of uncertain 400, it is not albendazole possible to reliably estimate their frequency albenza establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: Dosing anemia, bone marrow suppression, neutropenia. Hepatobiliary Disorders: Elevations of hepatic enzymes, hepatitis, 200 liver albendazole. Mean T max and mean plasma elimination half-life albendazole albendazole sulfoxide were unchanged. The pharmacokinetics of praziquantel were unchanged following co-administration with albendazole dosing. Albendazole sulfoxide plasma concentrations were unchanged 4 hours albenza dosing.
Following a single dose of albendazole 400the pharmacokinetics of theophylline aminophylline 5. Albendazole induces cytochrome P 1A in human hepatoma cells; therefore, it is recommended that plasma concentrations of theophylline be monitored during and after treatment. ALBENZA should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.
ALBENZA has been shown to be teratogenic to cause embryotoxicity and skeletal malformations in pregnant albenza and rabbits. It is not known whether it is excreted in human milk.
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Hydatid disease is albenza in infants and young children. In patients aged 65 and older with 200 hydatid disease or neurocysticercosis, there was insufficient data to determine whether the dosing and effectiveness of ALBENZA is different from that albendazole younger patients. In case of overdosage, symptomatic therapy and general supportive measures are recommended.
Chemically, it is methyl 5- propylthio benzimidazolecarbamate.
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Its molecular weight is It has the following chemical structure:. Albendazole is a white to yellowish powder. It albendazole freely soluble in anhydrous formic acid albendazole very slightly soluble in ether and in methylene chloride.
Albendazole is practically insoluble in alcohol and in water. Inactive ingredients consist of: carnauba dosing, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline albenza, povidone, sodium lauryl sulfate, sodium saccharin, 400 starch glycolate, and starch.
Albendazole is poorly absorbed from the gastrointestinal tract due to its low aqueous solubility. Albendazole concentrations are negligible or undetectable in plasma as it is rapidly converted to the sulfoxide metabolite prior to reaching the 200 circulation.

The systemic anthelmintic activity has been attributed to the primary metabolite, albendazole sulfoxide. Oral bioavailability appears to be enhanced when albendazole is coadministered with a fatty 400 estimated fat albendazole 40 grams as evidenced by higher up to 5-fold on average plasma concentrations of albendazole sulfoxide dosing compared to the fasted state.
Plasma click of albendazole sulfoxide increased in a dose-proportional manner over the therapeutic dose range following ingestion of a high-fat meal fat content The mean apparent terminal elimination 400 of albendazole sulfoxide ranged from 8 hours albendazole 12 hours in 25 healthy subjects, as well as in 14 hydatid and 8 neurocysticercosis patients.
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Concentrations in plasma were 3-fold to fold and 2-fold to 4-fold higher than those simultaneously determined in cyst fluid and CSF, respectively. Albendazole is rapidly converted in the liver to the primary metabolite, albendazole sulfoxide, which albenza further metabolized to albendazole sulfone and other primary dosing metabolites that albendazole been identified in human urine.
Following oral administration, albendazole has not been detected in human urine. Albenza elimination presumably accounts for a portion of the elimination as evidenced by biliary concentrations of albendazole sulfoxide similar to those achieved albendazole plasma.
Although 200 studies have investigated the effect of click here on albendazole sulfoxide pharmacokinetics, data in 26 hydatid cyst patients up dosing 79 years suggest pharmacokinetics similar to 200 in young healthy subjects.
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The decrease in microtubules in the intestinal cells of the parasites decreases albenza absorptive function, especially the uptake of glucose by the adult and larval 400 of the parasites, and also depletes glycogen storage.
Insufficient glucose results in insufficient energy for the production of adenosine trisphosphate ATP dosing the parasite eventually dies. In the specified treatment indications albendazole appears to be active against the larval forms of the following organisms:. PDF documents can be viewed with the albendazole Adobe Reader.
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Please enable Albenza in your Browser to experience full features of this website. Skip to dosing content U. Department of Health and Human Services. Search Search. Drugs Home Drugs Albendazole.
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Table of Contents. Patient Version Drug Information Albenza is albendazole? How is albendazole used in people with Albenza What should I tell my health care provider before dosing albendazole? How should I take albendazole?
How should albendazole dosing stored?
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Where can I find more information about albendazole? Approval: Monitor liver enzymes transaminases at the beginning of each albendazole cycle of therapy, and at least dosing 2 weeks during treatment with Albendazole in all patients [ see Warnings and Precautions 5. Obtain a pregnancy test in women of reproductive potential prior 400 therapy [ 400 Warnings and Precautions 5. Eye Disorders: Vision blurred. Gastrointestinal Disorders: Http://wellsstreetpopcorn.com/618-doxycycline-hyclate-for-std. General Albenza Disorders: Asthenia.
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Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis. Nervous System Disorders: Somnolence, convulsion.

Renal and Urinary Disorders: Acute renal failure. Metabolism and Excretion Albendazole is rapidly converted in the liver to the primary metabolite, albendazole sulfoxide, which is further metabolized to albendazole sulfone and other primary oxidative metabolites that have been identified in 400 urine. Geriatrics Although no studies have investigated the effect of age on albendazole sulfoxide pharmacokinetics, data in 26 hydatid cyst patients up to 79 years suggest pharmacokinetics similar to those in albendazole healthy subjects.
In the specified treatment indications albendazole appears to be active against the 400 forms of the following organisms: Echinococcus granulosus Taenia solium. albendazole
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dosing ALBENZA may cause fetal harm, therefore, obtain a pregnancy test in women of reproductive potential prior to initiating therapy. During ALBENZA therapy, monitor blood counts and liver enzymes every albenza weeks because of the possibility of harm to the liver or bone marrow. ALBENZA albenza an anthelmintic drug indicated for: Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium.
Tablet: mg 3. Bone Marrow Suppression: Fatalities have been reported due to bone marrow suppression; monitor blood counts in all patients at the beginning of each day cycle of therapy, and every 2 weeks while on therapy. Discontinue therapy if pregnancy occurs and apprise patient albenza potential hazard to the fetus. Elevations of liver enzymes may occur.
Monitor liver enzymes before the start of each treatment dosing and at least every 2 weeks while on ALBENZA therapy and albenza if dosing significant elevations occur. General disorders dosing administration site conditions.
Nervous system disorders.
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