To Demonstrate the Relative Bioavailability of Atenolol Tablets

Sandoz

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Atenolol Tablets 100 mg (Cord Laboratories); Drug: Atenolol Tablets 100 mg (Stuart Pharmaceutical)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913965

9103B

Details and patient eligibility

About

To demonstrate the relative bioavailability of Atenolol tablets.

Enrollment: 24 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion criteria

• Positive test results for HIV or hepatitis B or C.
• Treatment for drug or alcohol dependence.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

1

Experimental group

Description:

Atenolol Tablets 100 mg (Cord Laboratories)

Treatment:

Drug: Atenolol Tablets 100 mg (Cord Laboratories)

2

Active Comparator group

Description:

Atenolol Tablets 100 mg (Stuart Pharmaceutical)

Treatment:

Drug: Atenolol Tablets 100 mg (Stuart Pharmaceutical)