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NCT01188031 · ClinicalTrials.gov registry record · Phase 1
A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Fasting Conditions
A Phase 1 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01188031: Completed Phase 1 study, sponsored by Actavis.
NCT01188031 is a Phase 1 study that has completed, run by Actavis. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01188031, a Phase 1 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2 mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs Inc.®)following a single, oral dose (I x 2 mg disintegrating tablet) in healthy adult volunteers administered under fasting conditions.
Interventions
- DRUG ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG
- DRUG NIRAVAM TM 2 mg orally disintegrating tablets, single dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2006-06 |
| Est. Completion | 2006-07 |
| Phase | Phase 1 |
What the finished NCT01188031 record still lists
NCT01188031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG is the first listed.
NCT01188031 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01188031 about?
NCT01188031 is a clinical study titled "A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Fasting Conditions". This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2 mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs Inc.®)following a single, oral...
What is the current status of trial NCT01188031?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2006-06. Estimated completion is 2006-07.
What interventions are being tested in trial NCT01188031?
The interventions under investigation include: ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG (DRUG), NIRAVAM TM 2 mg orally disintegrating tablets, single dose (DRUG).
Who is sponsoring clinical trial NCT01188031?
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 NCT01188031's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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