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NCT00865631 · ClinicalTrials.gov registry record · Phase 1
A Limited Food Effect Study of Gabapentin 800 mg Tablets
A Phase 1 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00865631 is a Phase 1 study that has completed, run by Actavis. The registered enrollment target is 18 participants.
The verdict
NCT00865631, a Phase 1 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by Parke-Davis following a single oral dose (1 x 800 mg tablet) or (2 x 400 mg capsules) in healthy adult male volunteers under non-fasting conditions, and will compare the differences in plasma levels after dosing the test formulation with and without food.
Interventions
- DRUG Gabapentin 800 mg tablets, single dose (1 tablet)
- DRUG NEURONTIN® 400 mg capsules, single dose (2 capsules)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 1999-06 |
| Est. Completion | 1999-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00865631
The ClinicalTrials.gov registry entry for NCT00865631 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Gabapentin 800 mg tablets, single dose (1 tablet) is the first listed.
NCT00865631 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00865631 about?
NCT00865631 is a clinical study titled "A Limited Food Effect Study of Gabapentin 800 mg Tablets". The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by Parke-Davis following a single oral dose (1 x 800 mg tablet) or (2 x 400 mg capsules) in healthy adult male volunteers under ...
What is the current status of trial NCT00865631?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 1999-06. Estimated completion is 1999-06.
What interventions are being tested in trial NCT00865631?
The interventions under investigation include: Gabapentin 800 mg tablets, single dose (1 tablet) (DRUG), NEURONTIN® 400 mg capsules, single dose (2 capsules) (DRUG).
Who is sponsoring clinical trial NCT00865631?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
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