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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: Completed Phase 4 study, sponsored by ViiV Healthcare.
NCT02634073 is a Phase 4 study that has completed, run by ViiV Healthcare. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. AUC was determined using the trapezoidal rule. Analysis of variance (ANOVA), considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine Pharmacokinetic (PK) parameters.
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 |
What the finished NCT02634073 record still lists
NCT02634073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Lamivudine is the first listed.
NCT02634073 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02634073's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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