A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting Conditions

Sandoz

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline; Drug: Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00864981

B052005

Details and patient eligibility

About

The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 150 mg SR Tablets under fasting conditions.

Enrollment: 32 patients

Sex: All

Ages: 18+ 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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32 participants in 2 patient groups

1

Experimental group

Description:

Bupropion HCI ER Tablets, 150 mg

Treatment:

Drug: Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.

2

Active Comparator group

Description:

WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg

Treatment:

Drug: WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline