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Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions

2014-08-27 03:16:46 | BioPortfolio

Summary

The objective of this study is to evaluate the comparative bioavailability between bupropion hydrochloride 300 mg extended release tablets (Teva Pharmaceuticals USA) and Wellbutrin XL® 300 mg extended release tablets (Biovail Pharmaceuticals, Inc.) at steady-state in patients under fasting conditions.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Conditions

Depressive Disorder

Intervention

Bupropion HCl, Bupropion HCl

Location

California Clinical Trials
Culver City
California
United States
90232

Status

Recruiting

Source

Teva Pharmaceuticals USA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:46-0400

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Medical and Biotech [MESH] Definitions

A unicyclic, aminoketone antidepressant. The mechanism of its therapeutic actions is not well understood, but it does appear to block dopamine uptake. The hydrochloride is available as an aid to smoking cessation treatment.

A cytochrome P450 enzyme subtype that oxidizes a diverse array of XENOBIOTICS. The expression of CYP2B6 varies widely between individuals which is due to the high rate of GENETIC POLYMORPHISMS. Examples of drugs metabolized by CYP2B6 include BUPROPION; efavirenz; CYCLOPHOSPHAMIDE; and MEPERIDINE.

A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.

An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities. The mood disturbance is prominent and relatively persistent.

A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)

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