NCT01755637

Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population

A Single-dose, Two-centre, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Two Kinds of AlbendazoleTablet Formulations in Healthy Chinese Adult Males

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

Due to the product manufacture process change in Albendazole oral formulation from ethanol based granulation process to aqua based granulation process, State Food and Drug Administration officially requested Tianjin Smith Kline and French Laboratories to carry out a Bioequivalence study to demonstrate bioequivalence between the manufacturing processes. This trial will be conducted to support the official requirement via the comparison of the pharmacokinetic profiles between both the drugs manufactured under the different processes. After oral administration, Albendazole is quickly oxidized into its pharmacologically active metabolite, Albendazole sulphoxide (ABZ-SO. Due to extensive metabolism and limited absorption, plasma concentration of ABZ after oral administration was found to be too low to be measured. Thus, this trial will also compare the pharmacokinetic profiles of ABZ-SO manufactured using different solvents.

Conditions

• Helminthiasis

Interventions

Type	Name	Description
DRUG	Albendazole	Albendazole tablets 400 mg

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-04-01
• Completion: 2012-06-01
• First posted: 2012-12-24
• Last updated: 2013-07-15
• Results posted: 2013-07-15

Locations

2 sites across 1 country: China