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To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions

Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Bupropion HCl 100 mg Tablets (Invamed Inc.) (Drug); Wellbutrin 100 mg Tablets (Glaxo Wellcome) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sandoz Inc.

Official(s) and/or principal investigator(s):
Jameel Razack, M.D., Principal Investigator, Affiliation: Pharma Medica Research, Inc.

Summary

To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets under Fasting Conditions.

Clinical Details

Official title: To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions.

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence based on AUC and Cmax

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: October 1998
Last updated: April 16, 2009

Page last updated: August 23, 2015

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