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NCT00979537 · ClinicalTrials.gov registry record · Phase 1
Single-Dose Fed Bioequivalence Study of Nisoldipine Extended-Release Tablets (40 mg; Mylan) and Sular® Extended-Release Tablets (40 mg; First Horizon) in Healthy Volunteers
A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
- 1
- Study location
NCT00979537: Completed Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.
NCT00979537 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 83 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00979537, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study was to investigate the bioequivalence of nisoldipine extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg tablet) dose administration in healthy adult subjects under fed conditions.
Conditions Studied
Interventions
- DRUG Nisoldipine Extended-release Tablets, 40 mg
- DRUG Sular Tablets, 40 mg
Study Locations (1)
North Dakota
- Pracs Institute, Ltd - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2007-03 |
| Est. Completion | 2007-03 |
| Phase | Phase 1 |
What the finished NCT00979537 record still lists
NCT00979537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Nisoldipine Extended-release Tablets, 40 mg is the first listed.
NCT00979537 reports a single indexed study location in North Dakota.
Frequently Asked Questions
What is clinical trial NCT00979537 about?
NCT00979537 is a clinical study titled "Single-Dose Fed Bioequivalence Study of Nisoldipine Extended-Release Tablets (40 mg; Mylan) and Sular® Extended-Release Tablets (40 mg; First Horizon) in Healthy Volunteers". The objective of this study was to investigate the bioequivalence of nisoldipine extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg tablet) dose administration in healthy ...
What is the current status of trial NCT00979537?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2007-03. Estimated completion is 2007-03.
What conditions does trial NCT00979537 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00979537?
The interventions under investigation include: Nisoldipine Extended-release Tablets, 40 mg (DRUG), Sular Tablets, 40 mg (DRUG).
Who is sponsoring clinical trial NCT00979537?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00979537 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
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00979537's enrollment target sits among peer trials
83 271st of 1090 higher than 820 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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