A Limited Food Effect Study of Gabapentin 800 mg Tablets
Public ClinicalTrials.gov record NCT00865631. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Limited Food Effect Study of 800 mg Gabapentin Tablets Versus 400 mg Gabapentin Capsules
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00865631
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 18 participants
Conditions and interventions
Conditions
Interventions
- Gabapentin 800 mg tablets, single dose (1 tablet) Drug
- NEURONTIN® 400 mg capsules, single dose (2 capsules) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 1999 (Type not available)
- Primary completion
- Jun 1999 (Actual)
- Completion
- Jun 1999 (Actual)
- Last update posted
- Aug 17, 2010
1999
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| PRACS Institute, Ltd. | Fargo | North Dakota | 58102 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00865631, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 17, 2010 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00865631 live on ClinicalTrials.gov.