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NCT01948024 · ClinicalTrials.gov registry record · Phase 1
Bio-equivalence Study Between SAPHRIS and Asenapine
A Phase 1 study, sponsored by Sun Pharmaceutical Industries Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT01948024: Completed Phase 1 study, sponsored by Sun Pharmaceutical Industries Limited.
NCT01948024 is a Phase 1 study that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01948024, a Phase 1 study, has completed, sponsored by Sun Pharmaceutical Industries Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
This is a Multiple-dose, steady state, three-way reference-replicated crossover study. The purpose of this Study is to determine the bio-equivalence between SAPHRIS and Asenapine 10mg sublingual tablets.
Primary Outcome
The primary outcome of this Study is to show bio-equivalence between Asenapine and SAPHRIS. This will be accomplished by measuring the change in concentration of the study medication in the blood at multiple time-points.
Interventions
- DRUG SAPHRIS
- DRUG Asenapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2013-07 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
What the finished NCT01948024 record still lists
NCT01948024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which SAPHRIS is the first listed.
NCT01948024 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01948024 about?
NCT01948024 is a clinical study titled "Bio-equivalence Study Between SAPHRIS and Asenapine". This is a Multiple-dose, steady state, three-way reference-replicated crossover study. The purpose of this Study is to determine the bio-equivalence between SAPHRIS and Asenapine 10mg sublingual tablets.
What is the current status of trial NCT01948024?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2013-07. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01948024?
The interventions under investigation include: SAPHRIS (DRUG), Asenapine (DRUG).
Who is sponsoring clinical trial NCT01948024?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01948024's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 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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