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NCT01659931 · ClinicalTrials.gov registry record · Early Phase 1
Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions
A Early Phase 1 study of Asthma, sponsored by Roxane Laboratories.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT01659931: Completed Early Phase 1 study of Asthma, sponsored by Roxane Laboratories.
NCT01659931 is a Early Phase 1 study of Asthma that has completed, run by Roxane Laboratories. The registered enrollment target is 34 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01659931, a Early Phase 1 study of Asthma, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study was to prove the bioequivalence of Montelukast Tablet under fasted conditions
Conditions Studied
Interventions
- DRUG Montelukast
- DRUG Singulair
Study Locations (1)
North Dakota
- PRACS Institute, Ltd. - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2008-02 |
| Est. Completion | 2008-02 |
| Phase | Early Phase 1 |
What the finished NCT01659931 record still lists
NCT01659931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Montelukast is the first listed.
NCT01659931 reports a single indexed study location in North Dakota.
Frequently Asked Questions
What is clinical trial NCT01659931 about?
NCT01659931 is a clinical study titled "Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions". The objective of this study was to prove the bioequivalence of Montelukast Tablet under fasted conditions
What is the current status of trial NCT01659931?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 34 participants. The study started on 2008-02. Estimated completion is 2008-02.
What conditions does trial NCT01659931 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01659931?
The interventions under investigation include: Montelukast (DRUG), Singulair (DRUG).
Who is sponsoring clinical trial NCT01659931?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01659931 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01659931's enrollment target sits among peer trials
34 295th of 374 higher than 80 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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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