Relative Bioavailability Study of Nadolol (1 x 80 mg) Tablets Under Fasting Conditions

Sandoz

Status and phase: Completed; Phase 1

Conditions: Migraine Headaches; High Blood Pressure; Chest Pain

Treatments: Drug: Nadolol (1 x 80 mg) Tablets (Invamed, Inc); Drug: Corgard (1 x 80 mg) Tablets (Bristol Laboratories)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960245

PRACS P94-102

Details and patient eligibility

About

The purpose of this study is to demonstrate the relative bioavailability of Nadolol (1 x 80 mg) tablets under fasting conditions.

Enrollment: 34 patients

Sex: Male

Ages: 18 to 40 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)

---

34 participants in 2 patient groups

1

Experimental group

Description:

Nadolol (1 x 80 mg) Tablets (Invamed, Inc)

Treatment:

Drug: Nadolol (1 x 80 mg) Tablets (Invamed, Inc)

2

Active Comparator group

Description:

Corgard (1 x 80 mg) Tablets (Bristol Laboratories)

Treatment:

Drug: Corgard (1 x 80 mg) Tablets (Bristol Laboratories)