drugset / Trial / NCT04827134
A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants
RandomizedCrossoverOpen-labelTreatment
Summary
This study will assess the effect of food on the pharmacokinetics (PK) of pediatric formulations of TRIUMEQ (dolutegravir \[DTG\] 5 milligrams \[mg\]/abacavir \[ABC\] 60 mg/lamivudine \[3TC\] 30 mg) dispersible tablets and DOVATO (DTG 5 mg/3TC 30 mg) dispersible tablets in healthy adult participants. Additionally, safety and tolerability of these formulations will also be assessed. TRIUMEQ and DOVATO are registered trademarks of GlaxoSmithKline group of companies.
Timeline
- Start
- 2021-05-07
- Primary completion
- 2021-07-23
- Completion
- 2021-07-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abacavir | Other / unclassified | 60 mg | Oral |
| Subject | Dolutegravir | Other / unclassified | 5 mg | Oral |
| Subject | Lamivudine | Other / unclassified | 30 mg | Oral |