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

Mylan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Fosamax Tablets, 70 mg; Drug: Alendronate Sodium Tablets, 70 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01012934

ALEN-0244

Details and patient eligibility

About

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.

Enrollment: 110 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

110 participants in 2 patient groups

1

Experimental group

Description:

Alendronate Sodium Tablets, 70 mg

Treatment:

Drug: Alendronate Sodium Tablets, 70 mg

2

Active Comparator group

Description:

Fosamax Tablets, 70 mg

Treatment:

Drug: Fosamax Tablets, 70 mg