Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2002-12 |
| Est. Completion | 2003-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00648856
The ClinicalTrials.gov registry entry for NCT00648856 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
Learn More About Clinical Trials
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.
-
Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
RECRUITING · Phase 1
-
A Study of LY3867070 in Healthy Participants
RECRUITING · Phase 1
-
A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.
RECRUITING · Phase 1
-
Evaluate the Pharmacokinetics, Safety, and Tolerability of NSHO-101 in Healthy Participants
RECRUITING · Phase 1
-
Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Supplementation on Myocardial Glucose Suppression and Timing to Achieve a State of Ketosis Using FDG PET/CT Serial Imaging
RECRUITING · Phase 1
-
A Study of V118E in Healthy Participants (V118E-003)
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
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.