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NCT00864305 · ClinicalTrials.gov registry record · Phase 1
A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Non-fasting Conditions
A Phase 1 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00864305: Completed Phase 1 study, sponsored by Actavis.
NCT00864305 is a Phase 1 study that has completed, run by Actavis. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00864305, a Phase 1 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under non-fasting conditions, and to compare the differences in plasma levels after dosing the test formulation with and without food
Interventions
- DRUG Gabapentin 400 mg capsules
- DRUG NEURONTIN® 400 mg capsules
- DRUG Gabapentin 400 mg capsules, single dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 1997-12 |
| Est. Completion | 1998-01 |
| Phase | Phase 1 |
What the finished NCT00864305 record still lists
NCT00864305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Gabapentin 400 mg capsules is the first listed.
NCT00864305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00864305 about?
NCT00864305 is a clinical study titled "A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Non-fasting Conditions". To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under non-fasting conditions, and to compare the differences in plasma levels after dosing the test formulation with and without food
What is the current status of trial NCT00864305?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 1997-12. Estimated completion is 1998-01.
What interventions are being tested in trial NCT00864305?
The interventions under investigation include: Gabapentin 400 mg capsules (DRUG), NEURONTIN® 400 mg capsules (DRUG), Gabapentin 400 mg capsules, single dose (DRUG).
Who is sponsoring clinical trial NCT00864305?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00864305's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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