To Demonstrate the Relative Bioavailability of Bupropion HCI 300 mg Extended-Release Tablets Under Fasting Conditions

Sandoz

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: Bupropion HCI 300 mg Extended-Release Tablets EON; Drug: WELLBUTRIN XL 300 mg Extended-Release Tablets GlaxoSmithKline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00861939

B032032

Details and patient eligibility

About

The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 300 mg ER Tablets under fasting conditions.

Enrollment: 28 patients

Sex: All

Ages: 18 to 58 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 orc.
• 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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28 participants in 2 patient groups

1

Experimental group

Description:

Bupropion HCl 300mg Extended Release Tablet

Treatment:

Drug: Bupropion HCI 300 mg Extended-Release Tablets EON

2

Active Comparator group

Description:

WELLBUTRIN XL 300mg Tablets

Treatment:

Drug: WELLBUTRIN XL 300 mg Extended-Release Tablets GlaxoSmithKline