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Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg)

NCT00983996 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2009-09-24

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

DRUG

Alendronate Sodium Tablets, 10 mg

10 mg, single-dose fasting

DRUG

Fosamax Tablets, 10 mg

10 mg, single-dose fasting

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2002-07-31
Completion
2002-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00983996 on ClinicalTrials.gov