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NCT01340196 · ClinicalTrials.gov registry record · Phase 1
Drug Drug Interaction of BI 201335 and Tenofovir
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01340196: Completed Phase 1 study, sponsored by Boehringer Ingelheim.
NCT01340196 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01340196, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the drug-drug interaction potential between BI 201335 and concomitantly administered tenofovir which is used in treatment regimens for HIV infection and/or Hepatitis B infection. Results of this study will serve as a basis for guidance of dose adjustments or other precautionary measures when BI201335 and tenofovir are coadministered.
Primary Outcome
Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state.
Interventions
- DRUG tenofovir/BI 201335
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-04 |
| Phase | Phase 1 |
What the finished NCT01340196 record still lists
NCT01340196 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which tenofovir/BI 201335 is the first listed.
NCT01340196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01340196 about?
NCT01340196 is a clinical study titled "Drug Drug Interaction of BI 201335 and Tenofovir". The objective of this study is to evaluate the drug-drug interaction potential between BI 201335 and concomitantly administered tenofovir which is used in treatment regimens for HIV infection and/or Hepatitis B infection. Results of this study will serve as a basis for guidance of dose adjustments o...
What is the current status of trial NCT01340196?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2011-04.
What interventions are being tested in trial NCT01340196?
The interventions under investigation include: tenofovir/BI 201335 (DRUG).
Who is sponsoring clinical trial NCT01340196?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01340196's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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