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NCT00983996 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg)
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 112
- Enrollment target
NCT00983996 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 112 participants.
The verdict
NCT00983996, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 112 participants
- Enrollment target
Study Summary
The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 10 mg tablets to Merck's Fosamax 10 mg tablets following a single, oral 40 mg (4 x 10 mg) dose administration under fasting conditions.
Interventions
- DRUG Alendronate Sodium Tablets, 10 mg
- DRUG Fosamax Tablets, 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2002-06 |
| Est. Completion | 2002-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00983996
The ClinicalTrials.gov registry entry for NCT00983996 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 112 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 Alendronate Sodium Tablets, 10 mg is the first listed.
NCT00983996 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00983996 about?
NCT00983996 is a clinical study titled "Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg)". The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 10 mg tablets to Merck's Fosamax 10 mg tablets following a single, oral 40 mg (4 x 10 mg) dose administration under fasting conditions.
What is the current status of trial NCT00983996?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 112 participants. The study started on 2002-06. Estimated completion is 2002-07.
What interventions are being tested in trial NCT00983996?
The interventions under investigation include: Alendronate Sodium Tablets, 10 mg (DRUG), Fosamax Tablets, 10 mg (DRUG).
Who is sponsoring clinical trial NCT00983996?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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