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NCT00648531 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT00648531 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 80 participants.
The verdict
NCT00648531, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules and Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fasting conditions.
Interventions
- DRUG Balsalazide Disodium Capsules 750 mg
- DRUG Colazal® Capsules 750 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2004-05 |
| Est. Completion | 2004-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00648531
The ClinicalTrials.gov registry entry for NCT00648531 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Balsalazide Disodium Capsules 750 mg is the first listed.
NCT00648531 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00648531 about?
NCT00648531 is a clinical study titled "Fasting Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg". The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules and Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fasting conditions.
What is the current status of trial NCT00648531?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2004-05. Estimated completion is 2004-05.
What interventions are being tested in trial NCT00648531?
The interventions under investigation include: Balsalazide Disodium Capsules 750 mg (DRUG), Colazal® Capsules 750 mg (DRUG).
Who is sponsoring clinical trial NCT00648531?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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