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NCT01012934 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
NCT01012934: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT01012934 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 110 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01012934, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
Study Summary
The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 70 mg tablets to Merck's Fosamax 70 mg tablets following a single, oral 70 mg (1 x 70 mg) dose administration under fasting conditions.
Interventions
- DRUG Alendronate Sodium Tablets, 70 mg
- DRUG Fosamax Tablets, 70 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2002-07 |
| Est. Completion | 2002-08 |
| Phase | Phase 1 |
What the finished NCT01012934 record still lists
NCT01012934 is an interventional study that assigns participants to a tested intervention. The registered 110 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 (83% higher).
The record links to 0 conditions, and to 2 interventions - of which Alendronate Sodium Tablets, 70 mg is the first listed.
NCT01012934 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01012934 about?
NCT01012934 is a clinical study titled "Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)". The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 70 mg tablets to Merck's Fosamax 70 mg tablets following a single, oral 70 mg (1 x 70 mg) dose administration under fasting conditions.
What is the current status of trial NCT01012934?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2002-07. Estimated completion is 2002-08.
What interventions are being tested in trial NCT01012934?
The interventions under investigation include: Alendronate Sodium Tablets, 70 mg (DRUG), Fosamax Tablets, 70 mg (DRUG).
Who is sponsoring clinical trial NCT01012934?
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 NCT01012934's enrollment target sits among peer trials
110 514th of 2000 higher than 1,479 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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