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NCT01659892 · ClinicalTrials.gov registry record · Early Phase 1
Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions
A Early Phase 1 study, sponsored by Roxane Laboratories.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 36
- Enrollment target
NCT01659892: Completed Early Phase 1 study, sponsored by Roxane Laboratories.
NCT01659892 is a Early Phase 1 study that has completed, run by Roxane Laboratories. The registered enrollment target is 36 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01659892, a Early Phase 1 study, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fed conditions
Interventions
- DRUG Montelukast
- DRUG Singulair
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2008-08 |
| Est. Completion | 2008-08 |
| Phase | Early Phase 1 |
What the finished NCT01659892 record still lists
NCT01659892 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Montelukast is the first listed.
NCT01659892 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01659892 about?
NCT01659892 is a clinical study titled "Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions". The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fed conditions
What is the current status of trial NCT01659892?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 36 participants. The study started on 2008-08. Estimated completion is 2008-08.
What interventions are being tested in trial NCT01659892?
The interventions under investigation include: Montelukast (DRUG), Singulair (DRUG).
Who is sponsoring clinical trial NCT01659892?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01659892's enrollment target sits among peer trials
36 712th of 2000 higher than 1,267 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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