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NCT01659918 · ClinicalTrials.gov registry record · Early Phase 1
Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions
A Early Phase 1 study of Asthma, sponsored by Roxane Laboratories.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT01659918 is a Early Phase 1 study of Asthma that has completed, run by Roxane Laboratories. The registered enrollment target is 35 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.
The verdict
NCT01659918, a Early Phase 1 study of Asthma, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study was to prove the bioequivalence of Montelukast Tablet under fed conditions
Conditions Studied
Interventions
- DRUG Montelukast
- DRUG Singulair
Study Locations (1)
North Dakota
- PRACS Institute, Ltd. - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2008-02 |
| Est. Completion | 2008-02 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01659918
The ClinicalTrials.gov registry entry for NCT01659918 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.
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.
NCT01659918 reports 1 study location spanning 1 distinct geographic area - top geographies include North Dakota.
Frequently Asked Questions
What is clinical trial NCT01659918 about?
NCT01659918 is a clinical study titled "Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions". The objective of this study was to prove the bioequivalence of Montelukast Tablet under fed conditions
What is the current status of trial NCT01659918?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 35 participants. The study started on 2008-02. Estimated completion is 2008-02.
What conditions does trial NCT01659918 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01659918?
The interventions under investigation include: Montelukast (DRUG), Singulair (DRUG).
Who is sponsoring clinical trial NCT01659918?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01659918 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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