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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

NCT number NCT05030025
Study type Interventional
Source Mylan Inc.
Contact Erin R Larnerd
Phone 304-554-5844
Email [email protected]
Status Recruiting
Phase Early Phase 1
Start date August 1, 2021
Completion date December 31, 2021

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