Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg)
Public ClinicalTrials.gov record NCT00983996. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (10 mg; Mylan) and Fosamax Tablets (10 mg; Merck) in Healthy Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00983996
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 112 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2002
- Primary completion
- Jun 30, 2002
- Completion
- Jun 30, 2002
- Last update posted
- Sep 23, 2009
2002
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| PRACS Insitute Ltd. | Fargo | North Dakota | 58104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00983996, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 23, 2009 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00983996 live on ClinicalTrials.gov.