NCT05030025

Abacavir, Dolutegravir and Lamivudine Dispersible Tablets (60 mg/5 mg/30 mg)

Single-Dose Fasting and Fed Pilot BE Study in Healthy Males and Females Not of Childbearing Potential

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The rationale for this study is to evaluate and understand the variability of a generic alternative of abacavir, dolutegravir and lamivudine dispersible tablets for PEPFAR submission to aide in the development of pivotal studies.

Detailed description

This study is to investigate the bioequivalence of Mylan's abacavir, dolutegravir and lamivudine dispersible tablets, 60 mg/5 mg/30 mg to ViiV's Triumeq Dispersible Tablets (5 mg GSK1349572 \[dolutegravir\]/ 60 mg abacavir/ 30 mg lamivudine) following administration of a single, oral 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg) dose of Mylan's abacavir, dolutegravir and lamivudine dispersible tablets or ViiV's Triumeq Dispersible Tablets administered under fasting and fed conditions. Adverse events will be monitored to ensure the safety and well-being of the healthy volunteers.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
COMBINATION_PRODUCT	abacavir, dolutegravir and lamivudine dispersible tablets	Abacavir, Dolutegravir and Lamivudine Dispersible Tablets, 60 mg/5 mg/30 mg Dose: 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg)
COMBINATION_PRODUCT	Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine	Triumeq Dispersible Tablets 5 mg GSK1349572 \[Dolutegravir\]/ 60 mg Abacavir/ 30 mg Lamivudine Dose: 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg)

Timeline

• Start date: 2021-08-01
• Primary completion: 2021-08-29
• Completion: 2021-08-29
• First posted: 2021-09-01
• Last updated: 2022-03-25

Locations

1 site across 1 country: Canada