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NCT03441984 · ClinicalTrials.gov registry record · Phase 1
To Assess the Relative Bioavailability (BA) of TRIUMEQ® and Dolutegravir and Lamivudine (DTG/3TC) Pediatric Dispersible Tablet Formulations in Healthy Volunteers
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT03441984 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 36 participants.
The verdict
NCT03441984, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is a 2-part, single-dose, open label, randomized 3-way cross-over study to compare BA of pediatric study drugs TRIUMEQ and (DTG/3TC) in healthy volunteers under fasted conditions. Study will be conducted in 2-parts. Each part 1 and part 2 will comprise of 3-treatment periods (TP) where Part 1, will assess BA, of pediatric TRIUMEQ dispersible tablets with an adult TRIUMEQ conventional tablet formulation and Part 2, will assess BA, of pediatric DTG/3TC dispersible tablets with adult DTG and 3TC conventional tablets formulation. Total duration of study is 9-weeks and will be conducted in approximately 36 subjects. The 2-parts, may be run in parallel as they are independent of each other. TRIUMEQ is a registered trademark of GlaxoSmithKline group of companies.
Interventions
- DRUG Treatment A
- DRUG Treatment B
- DRUG Treatment C
- DRUG Treatment D
- DRUG Treatment E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-02-26 |
| Est. Completion | 2018-04-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03441984
The ClinicalTrials.gov registry entry for NCT03441984 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Treatment A is the first listed.
NCT03441984 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03441984 about?
NCT03441984 is a clinical study titled "To Assess the Relative Bioavailability (BA) of TRIUMEQ® and Dolutegravir and Lamivudine (DTG/3TC) Pediatric Dispersible Tablet Formulations in Healthy Volunteers". This is a 2-part, single-dose, open label, randomized 3-way cross-over study to compare BA of pediatric study drugs TRIUMEQ and (DTG/3TC) in healthy volunteers under fasted conditions. Study will be conducted in 2-parts. Each part 1 and part 2 will comprise of 3-treatment periods (TP) where Part 1, ...
What is the current status of trial NCT03441984?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2018-02-26. Estimated completion is 2018-04-28.
What interventions are being tested in trial NCT03441984?
The interventions under investigation include: Treatment A (DRUG), Treatment B (DRUG), Treatment C (DRUG), Treatment D (DRUG), Treatment E (DRUG).
Who is sponsoring clinical trial NCT03441984?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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