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NCT00834197 · ClinicalTrials.gov registry record · Phase 1
15 mg Mirtazapine Orally Disintegrating Tablets, Non-Fasting
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00834197: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT00834197 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00834197, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries, Ltd.; distributed by TEVA Pharmaceuticals USA with that of 15 mg REMERON SolTab® Orally Disintegrating Tablets manufactured for Organon Inc. by CIMA Labs Inc. following a single oral dose (1 x 15 mg) in healthy adult subjects under non-fasting conditions.
Primary Outcome
Bioequivalence based on Cmax.
Interventions
- DRUG Mirtazapine 15 mg (Orally Disintegrating) Tablets
- DRUG REMERON SolTab® 15 mg Orally Disintegrating Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2003-07 |
| Est. Completion | 2003-08 |
| Phase | Phase 1 |
What the finished NCT00834197 record still lists
NCT00834197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Mirtazapine 15 mg (Orally Disintegrating) Tablets is the first listed.
NCT00834197 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00834197 about?
NCT00834197 is a clinical study titled "15 mg Mirtazapine Orally Disintegrating Tablets, Non-Fasting". This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries, Ltd.; distributed by TEVA Pharmaceuticals USA with that of 15 mg REMERON SolTab® Orally Disintegrating Tablets man...
What is the current status of trial NCT00834197?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2003-07. Estimated completion is 2003-08.
What interventions are being tested in trial NCT00834197?
The interventions under investigation include: Mirtazapine 15 mg (Orally Disintegrating) Tablets (DRUG), REMERON SolTab® 15 mg Orally Disintegrating Tablets (DRUG).
Who is sponsoring clinical trial NCT00834197?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00834197's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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