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

Mylan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Alendronate Sodium Tablets, 10 mg; Drug: Fosamax Tablets, 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00983996

ALEN-0243

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

112 participants in 2 patient groups

1

Experimental group

Description:

Alendronate Sodium Tablets, 10 mg

Treatment:

Drug: Alendronate Sodium Tablets, 10 mg

2

Active Comparator group

Description:

Fosamax Tablets, 10 mg

Treatment:

Drug: Fosamax Tablets, 10 mg