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NCT00865384 · ClinicalTrials.gov registry record · Phase 1
A Relative Bioavailability Study of Mirtazapine 15 mg Tablets Under Non-fasting Conditions
A Phase 1 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00865384: Completed Phase 1 study, sponsored by Actavis.
NCT00865384 is a Phase 1 study that has completed, run by Actavis. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00865384, a Phase 1 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the relative bioavailability of 15 mg Mirtazapine Tablets by Purepac Pharmaceutical Co with that of 15 mg REMERON® Tablets by Organon Inc. following a single oral dose (1 x 15 mg) in healthy adult volunteers under non-fasting conditions.
Interventions
- DRUG Mirtazapine 15 mg tablets, single dose
- DRUG REMERON® 15 mg tablets, single dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2001-09 |
| Est. Completion | 2001-09 |
| Phase | Phase 1 |
What the finished NCT00865384 record still lists
NCT00865384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Mirtazapine 15 mg tablets, single dose is the first listed.
NCT00865384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00865384 about?
NCT00865384 is a clinical study titled "A Relative Bioavailability Study of Mirtazapine 15 mg Tablets Under Non-fasting Conditions". The purpose of this study is to compare the relative bioavailability of 15 mg Mirtazapine Tablets by Purepac Pharmaceutical Co with that of 15 mg REMERON® Tablets by Organon Inc. following a single oral dose (1 x 15 mg) in healthy adult volunteers under non-fasting conditions.
What is the current status of trial NCT00865384?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2001-09. Estimated completion is 2001-09.
What interventions are being tested in trial NCT00865384?
The interventions under investigation include: Mirtazapine 15 mg tablets, single dose (DRUG), REMERON® 15 mg tablets, single dose (DRUG).
Who is sponsoring clinical trial NCT00865384?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00865384's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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