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NCT02725112 · ClinicalTrials.gov registry record · Phase 1
Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers
A Phase 1 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT02725112: Completed Phase 1 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT02725112 is a Phase 1 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02725112, a Phase 1 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
This study is a Phase 1, randomized, open label, single dose, 6 treatment, 6 period, 6 sequence study in healthy adult volunteers. A total of 24 (4 in each treatment sequence) healthy male and female subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive will be enrolled. Subjects who discontinue from the study may be replaced at the Sponsor's discretion. Screening activities will be completed within approximately 28 days prior to Day 1 of Period 1. Subjects will be randomized to 1 of the 6 treatment sequences as described in Table 1 below. Each treatment sequence will consist of 6 periods with subjects receiving single doses of pregabalin ER 330 mg target release rate tablet, pregabalin ER 330 mg slow release rate tablet, pregabalin ER 330 mg fast release rate tablet, pregabalin IR 300 mg capsule, pregabalin ER 82.5 mg target release rate tablet, and pregabalin ER 330 mg aberrant fast release rate tablet formulations. All study treatments will be administered following a 600- 750 calorie, 30% fat evening meal.
Primary Outcome
To evaluate the relative bioavailability of pregabalin ER 330 mg slow and fast release rate tablet formulations administered immediately following an evening meal.
Interventions
- DRUG Pregabalin ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2016-02-12 |
| Est. Completion | 2016-06-17 |
| Phase | Phase 1 |
What the finished NCT02725112 record still lists
NCT02725112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Pregabalin ER is the first listed.
NCT02725112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02725112 about?
NCT02725112 is a clinical study titled "Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers". This study is a Phase 1, randomized, open label, single dose, 6 treatment, 6 period, 6 sequence study in healthy adult volunteers. A total of 24 (4 in each treatment sequence) healthy male and female subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive will be e...
What is the current status of trial NCT02725112?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2016-02-12. Estimated completion is 2016-06-17.
What interventions are being tested in trial NCT02725112?
The interventions under investigation include: Pregabalin ER (DRUG).
Who is sponsoring clinical trial NCT02725112?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02725112's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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