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NCT03051685 · ClinicalTrials.gov registry record · Phase 1
Bioavailability of DFN-15 at 3 Different Doses vs. Comparator and to Determine Dose-proportionality of DFN-15 in Fasting Healthy Adults
A Phase 1 study, sponsored by Dr. Reddy's Laboratories Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03051685: Completed Phase 1 study, sponsored by Dr. Reddy's Laboratories Limited.
NCT03051685 is a Phase 1 study that has completed, run by Dr. Reddy's Laboratories Limited. 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
NCT03051685, a Phase 1 study, has completed, sponsored by Dr. Reddy's Laboratories Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Crossover study to compare the BA of DFN-15 at 3 different doses versus the comparator to determine dose-proportionality of DFN-15 in healthy volunteers under fasting conditions
Primary Outcome
DFN-15 maximum Plasma Concentration (Cmax)
Interventions
- DRUG Active Comparator
- DRUG DFN-15 Dose 1
- DRUG DFN-15 Dose 2
- DRUG DFN-15 Dose 3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-07-20 |
| Est. Completion | 2015-11-10 |
| Phase | Phase 1 |
What the finished NCT03051685 record still lists
NCT03051685 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 4 interventions - of which Active Comparator is the first listed.
NCT03051685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03051685 about?
NCT03051685 is a clinical study titled "Bioavailability of DFN-15 at 3 Different Doses vs. Comparator and to Determine Dose-proportionality of DFN-15 in Fasting Healthy Adults". Crossover study to compare the BA of DFN-15 at 3 different doses versus the comparator to determine dose-proportionality of DFN-15 in healthy volunteers under fasting conditions
What is the current status of trial NCT03051685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2015-07-20. Estimated completion is 2015-11-10.
What interventions are being tested in trial NCT03051685?
The interventions under investigation include: Active Comparator (DRUG), DFN-15 Dose 1 (DRUG), DFN-15 Dose 2 (DRUG), DFN-15 Dose 3 (DRUG).
Who is sponsoring clinical trial NCT03051685?
This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03051685'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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