Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)

Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (70 mg; Mylan) and Fosamax Tablets (70 mg; Merck) in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01012934

Enrollment

110

Registered

2009-11-13

Start date

2002-07-31

Completion date

2002-08-31

Last updated

2009-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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

DRUGAlendronate Sodium Tablets, 70 mg

1 x 70 mg, single-dose fasting

DRUGFosamax Tablets, 70 mg

1 x 70 mg, single-dose fasting

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* healthy, adult subjects, 18 years and older * able to swallow medication

Exclusion criteria

* institutionalized subjects * history of any significant disease * use of any prescription or OTC medications within 14 days of start of study * received any investigational products within 30 days prior to start of study

Design outcomes

Primary

Measure	Time frame
The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.	urine collection up to 36 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026