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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 is a Phase 1 study that has completed, run by Actavis. The registered enrollment target is 18 participants.

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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

FieldValue
Enrollment Target 18 participants
Start Date 1997-12
Est. Completion 1998-01
Phase Phase 1

Sponsor

Actavis

79 total trials

What the Registry Record Tells You About NCT00864305

The ClinicalTrials.gov registry entry for NCT00864305 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 3 interventions - of which Gabapentin 400 mg capsules is the first listed.

NCT00864305 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.