NCT06201559

Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions

An Open Label, Balanced, Randomized, Two-Treatment, Four-Period, Two-Sequence, Single Oral Dose, Full Replicate Crossover, Bioequivalence Study of Albendazole Tablets IP 400 mg of Biddle Sawyer Limited (GSK Group Company) With Albendazole Tablets 400 mg of Glaxo SmithKline Consumer Healthcare, South Africa (PTY) Ltd in Healthy, Adult Participants Under Fed Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to compare two formulations of Albendazole of the same dose in healthy adult participants. Researchers will compare the extent and rate to which the drug is absorbed.

Conditions

• Intestinal Diseases

Interventions

Type	Name	Description
DRUG	Albendazole IP 400 mg	Albendazole IP 400 mg tablets will be administered under fed conditions
DRUG	Albendazole 400 mg	Albendazole 400 mg tablets will be administered under fed conditions

Timeline

• Start date: 2023-08-21
• Primary completion: 2023-09-12
• Completion: 2023-09-12
• First posted: 2024-01-11
• Last updated: 2025-01-27
• Results posted: 2025-01-27

Locations

1 site across 1 country: India