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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
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)
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)
Altasciences
Montreal, Quebec, Canada
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Time frame: 2 weeks
Area under the plasma concentration versus time curve (AUC) 0-t
Plasma concentration-time curve from zero to the time of the last measurable time point t
Time frame: 2 weeks
Area under the plasma concentration versus time curve (AUC)0-∞
Area under the plasma concentration-time curve from zero to infinity
Time frame: 2 weeks
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