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NCT02634073 · ClinicalTrials.gov registry record · Phase 4
A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers
A Phase 4 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT02634073 is a Phase 4 study that has completed, run by ViiV Healthcare. The registered enrollment target is 16 participants.
The verdict
NCT02634073, a Phase 4 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
Lamivudine (3TC) is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children. Documented literature elucidates that simultaneous administration of multiple sorbitol-containing products could increase the potential for a significant interaction and may contribute to the lower 3TC exposures. In this study several sorbitol doses (3.2 gram (g), 10.2 g, and 13.4 g solutions) will be administered with lamivudine to investigate dose dependency and mimic the situation where multiple sorbitol-containing antiretroviral medications may be co-administered with lamivudine. It will be open label, randomized, 4-way crossover (by William's design method) design at a single centre. Randomized participants will receive a single dose of each of four treatments after wash out period of minimum 7 days.
Interventions
- DRUG Lamivudine
- DRUG Sorbitol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2016-01-01 |
| Est. Completion | 2016-03-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02634073
The ClinicalTrials.gov registry entry for NCT02634073 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 16 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 2 interventions - of which Lamivudine is the first listed.
NCT02634073 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02634073 about?
NCT02634073 is a clinical study titled "A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers". Lamivudine (3TC) is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children. Documented literature elucidates that simultaneous administration of multiple sorbitol-containing pro...
What is the current status of trial NCT02634073?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2016-01-01. Estimated completion is 2016-03-11.
What interventions are being tested in trial NCT02634073?
The interventions under investigation include: Lamivudine (DRUG), Sorbitol (DRUG).
Who is sponsoring clinical trial NCT02634073?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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