Phase 1 N=56 Randomized Treatment

Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population

Helminthiasis

Bottom Line

View on ClinicalTrials.gov: NCT01755637 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole. — 54.82; 48.07 nanogram (ng).hr per milliliter (mL)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Albendazole (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: GlaxoSmithKline
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole.	54.82; 48.07	—
PRIMARY AUC [0-infinity (Inf)] of Albendazole	69.55; 67.19	—
PRIMARY Maximum Observed Plasma Concentration [Cmaximum (Max)] of Albendazole	14.76; 14.58	—
SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of Albendazole	1.50; 1.00	0.0011 sig
SECONDARY AUC (0-t) of Active Metabolite - Albendazole Sulphoxide	2563.90; 2290.14	—
SECONDARY AUC (0-inf) of Active Metabolite - Albendazole Sulphoxide	3263.88; 2829.77	—
SECONDARY Cmax of Active Metabolite - Albendazole Sulphoxide	221.45; 199.99	—

Summary

The purpose of the study is to compare the pharmacokinetic profiles of two Albendazole tablet formulations manufactured under the different granulation processes in healthy Chinese adult males.

Eligibility Criteria

Inclusion Criteria

Male aged from 18 years up to 40 years (inclusive).
Body mass index within the range of 19-24kg/m^2.
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
Negative for serum hepatitis B surface antigen, hepatitis C antibody and antibody of HIV.

Exclusion Criteria

Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Substance abuse: Recent history (within the last year) of alcohol or other substance abuse or failed to pass drugs of abuse screen and/or alcohol screen test.
Disease
Current or recurrent disease that could affect the action, absorption or distribution of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, abnormal liver function tests, renal insufficiency, congestive heart failure);
Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures;
History of gastrointestinal bleeding or peptic ulcer;
Asthma
History of liver disease
Medication
Use of any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing
Current or regular use of any prescription or over-the-counter medication, any other ABZ containing products, and traditional Chinese medicine.
Smoking
Subjects who are current smokers or non-smokers of less than 3 months;
Prior (within seven days of dosing) or current use of any other nicotine containing products, including nicotine replacement therapy.
Blood
Blood donation ≥ 500 ml within 90 days before the first study session.
Plasma donation within the 90 days before the first study session.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01755637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.