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NCT00648193 · ClinicalTrials.gov registry record · Early Phase 1

Fasting Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg

A Early Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Early Phase 1
Development phase
36
Enrollment target

NCT00648193 is a Early Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 36 participants.

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The verdict

NCT00648193, a Early Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Early Phase 1
Development phase
36 participants
Enrollment target

Study Summary

The objective of this study is to investigate the bioequivalence of Mylan's paroxetine hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions to healthy adult volunteers.

Interventions

  • DRUG Paroxetine hydrochloride 40 mg tablet
  • DRUG Paxil® 40 mg Table

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2006-12
Est. Completion 2007-01
Phase Early Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00648193

The ClinicalTrials.gov registry entry for NCT00648193 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Paroxetine hydrochloride 40 mg tablet is the first listed.

NCT00648193 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00648193 about?

NCT00648193 is a clinical study titled "Fasting Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg". The objective of this study is to investigate the bioequivalence of Mylan's paroxetine hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions to healthy adult volunteers.

What is the current status of trial NCT00648193?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 36 participants. The study started on 2006-12. Estimated completion is 2007-01.

What interventions are being tested in trial NCT00648193?

The interventions under investigation include: Paroxetine hydrochloride 40 mg tablet (DRUG), Paxil® 40 mg Table (DRUG).

Who is sponsoring clinical trial NCT00648193?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 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.