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Single-Dose Fasting and Fed Pilot BE Study in Healthy Males and Females Not of Childbearing Potential
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.
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.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
Altasciences
Montreal, Quebec, Canada
Start Date
August 1, 2021
Primary Completion Date
August 29, 2021
Completion Date
August 29, 2021
Last Updated
March 25, 2022
43
ACTUAL participants
abacavir, dolutegravir and lamivudine dispersible tablets
COMBINATION_PRODUCT
Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine
COMBINATION_PRODUCT
Lead Sponsor
Mylan Inc.
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05668026