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

HIV-1-infection Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05030025
Study type Interventional
Source Viatris Inc.
Contact
Status Completed
Phase Early Phase 1
Start date August 1, 2021
Completion date August 29, 2021
View Details
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