NCT06450275

Bioequivalence Study to Compare Dolutegravir 50mg Film-coated Tablets

Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Dolutegravir 50mg Film-coated Tablets (50mg Dolutegravir) Versus Tivicay 50mg Film-coated Tablets (50mg Dolutegravir) in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Dolutegravir 50mg film-coated tablets (50mg Dolutegravir) versus Tivicay 50mg film-coated tablets (50mg Dolutegravir) in healthy subjects under fasting conditions.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Dolutegravir 50 MG Film Coated Tablet	1 tablet of Dolutegravir 50mg film-coated tablets
DRUG	Tivicay 50mg, film-coated tablets	1 tablet of Dolutegravir 50mg film-coated tablets

Timeline

• Start date: 2024-01-03
• Primary completion: 2024-01-15
• Completion: 2024-03-07
• First posted: 2024-06-10
• Last updated: 2024-06-10

Locations

1 site across 1 country: Jordan