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NCT00648856 · ClinicalTrials.gov registry record · Phase 1

Food Study of Sertraline Hydrochloride Tablets 100 mg and Zoloft® Tablets 100 mg

A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target
1
Study location

NCT00648856: Completed Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.

NCT00648856 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 21 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00648856, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target
1
Study location

Study Summary

The objective of this study was to investigate the bioequivalence of Mylan's sertraline hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administration under fed conditions.

Conditions Studied

Interventions

  • DRUG Sertraline Hydrochloride Tablets 100 mg
  • DRUG Zoloft® Tablets 100 mg

Study Locations (1)

West Virginia

  • Kendle International Inc. - Morgantown

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2002-12
Est. Completion 2003-01
Phase Phase 1
Mylan Pharmaceuticals

146 total trials

What the finished NCT00648856 record still lists

NCT00648856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower).

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Sertraline Hydrochloride Tablets 100 mg is the first listed.

NCT00648856 reports a single indexed study location in West Virginia.

Frequently Asked Questions

What is clinical trial NCT00648856 about?

NCT00648856 is a clinical study titled "Food Study of Sertraline Hydrochloride Tablets 100 mg and Zoloft® Tablets 100 mg". The objective of this study was to investigate the bioequivalence of Mylan's sertraline hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administration under fed conditions.

What is the current status of trial NCT00648856?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2002-12. Estimated completion is 2003-01.

What conditions does trial NCT00648856 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00648856?

The interventions under investigation include: Sertraline Hydrochloride Tablets 100 mg (DRUG), Zoloft® Tablets 100 mg (DRUG).

Who is sponsoring clinical trial NCT00648856?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00648856 being conducted?

This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00648856's enrollment target sits among peer trials

21 857th of 1090 higher than 231 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy 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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Source: ClinicalTrials.gov NCT00648856, the US trial registry maintained by the National Library of Medicine. NCT00648856 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.