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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: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00983996 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 112 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00983996 record still lists
NCT00983996 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% higher).
The record links to 0 conditions, and to 2 interventions - of which Alendronate Sodium Tablets, 10 mg is the first listed.
NCT00983996 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00983996's enrollment target sits among peer trials
112 508th of 2000 higher than 1,489 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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