6.2.2
FOOD-EFFECT
STUDY
A TWO-WAY, CROSSOVER, OPEN-LABEL, SINGLE DOSE, FOOD-EFFECT, COMPARATIVE BIOAVAILABILITY STUDY OF BUPROPION HCL EXTENDED RELEASE 300 MG TABLETS IN NORMAL HEALTHY NON-SMOKING MALE AND FEMALE SUBJECTS
Study Investigators and Site:
Paul
Y. Tam, MD, FRCP, FACP
Biovail
Contract Research
Toronto,
Ontario, Canada
Protocol
Number:
AK1BIOVAIL2548
OBJECTIVES:
To evaluate the effect of food on the rate and extent of absorption of a once daily formulation of bupropion hydrochloride (HCl) extended release tablets (300 mg) under single-dose conditions.
FORMULATIONS:
Table 1. Product used in AK1BIOVAIL2548
|
|
Package
Lot Number |
Dose
Form Lot
Number |
Manufacture
Date (Dates
of Study) |
|
Bupropion
HCl 300 mg extended release tablets (Biovail Corporation, USA) |
01K211 |
01K088 |
October
2001 (January
26, 2002 – February
15, 2002) |
Stability
studies were ongoing at the time of review.
According to the Sponsor, the test product was stable for at least 9
months.
STUDY
DESIGN:
This study was a single dose, open-label, randomized, 2-period, 2-treatment, 2-sequence crossover study, as shown in Table 1, below. For Treatment A, subjects received a single dose of bupropion HCl extended release 300 mg tablet with 240 ml of ambient temperature water following an overnight fast of at least 10 hours 9treatment period R). Additional water was not allowed from 1 hour pre-dose until 1 hour after dose. Food was not given until more than 4 hours after the dose. For Treatment B, subjects received a single dose of bupropion HCl extended release 300 mg tablet with 240 ambient temperature water within 5 minutes following the complete ingestion of a high-fat content breakfast (treatment period T). Additional food was not given until more than 4 hours after the dose. Additional water was not allowed from 1 hour pre-dose until 1 hour after dose. There was a 2-week washout between study periods. The 300 mg dose of the extended release product is the highest proposed dosage strength of this product.
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