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OpenTrials
Completed

NCT Number: NCT00983996

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRACS Insitute Ltd.

Fargo, North Dakota, 58104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alendronate Sodium Tablets, 10 mg

Drug

10 mg, single-dose fasting

Fosamax Tablets, 10 mg

Drug

10 mg, single-dose fasting

Primary outcomes

  1. Bioequivalence

    Time frame: urine collection up to 36 hours

Sponsors and collaborators

Lead sponsor

Mylan Pharmaceuticals Inc

Industry

Registry information

Official study title

Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (10 mg; Mylan) and Fosamax Tablets (10 mg; Merck) in Healthy Volunteers

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Sep 24, 2009
Registry last updated
Sep 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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