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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2002-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

Alendronate Sodium Tablets, 70 mg

Group Type EXPERIMENTAL

Alendronate Sodium Tablets, 70 mg

Intervention Type DRUG

1 x 70 mg, single-dose fasting

2

Fosamax Tablets, 70 mg

Group Type ACTIVE_COMPARATOR

Fosamax Tablets, 70 mg

Intervention Type DRUG

1 x 70 mg, single-dose fasting

Interventions

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Alendronate Sodium Tablets, 70 mg

1 x 70 mg, single-dose fasting

Intervention Type DRUG

Fosamax Tablets, 70 mg

1 x 70 mg, single-dose fasting

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes