6.2.3
DOSAGE
STRENGTH EQUIVALENCE
A TWO-WAY, CROSSOVER, OPEN-LABEL, SINGLE DOSE, FASTING, DOSAGE STRENGTH EQUIVALENCY STUDY OF TWO STRENGTHS (150 MG AND 300 MG) OF BUPROPION HCL EXTENDED RELEASE TABLETS GIVEN ONCE DAILY 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:
AK1BIOVAIL2571
OBJECTIVES:
To
investigate the dosage strength equivalency of the 150 mg and 300 mg product
strengths of bupropion hydrochloride extended release tablets under fasting
conditions.
FORMULATIONS:
Table 1. Product used in AK1BIOVAIL2571
|
|
Package
Lot Number |
Dose
Form Lot
Number |
Date
of Manufacture (Dates
of Study) |
|
Bupropion
HCl 150 mg extended release tablets
(Biovail Corporation, Canada) |
02A063 |
01M174 |
November
2001 January
24, 2002 – March
19, 2002 |
|
Bupropion
HCl 300 mg extended release tablets
(Biovail Corporation, Canada) |
01L238 |
01L008 |
October
2001 January
24, 2002 – March
19, 2002 |
Long-term stability studies were ongoing at the time of this review. The product appeared to be stable for 6-9 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, [Table
2] below. For Treatment A,
subjects received a single dose of (2) bupropion HCl extended release 150 mg
tablets (test). For Treatment B,
subjects received a single dose of bupropion HCl extended release 300 mg tablet
(reference). Study drug was given with
240 ml of room temperature water following an overnight fast of at least 10
hours. Additional water was not allowed
from 1 hour pre-dose until 1 hour after dose.
Standardized meals were provided with beverages at 4.5 and 9.5 hours
after the dose, and an additional standardized snack was provided at 13.5 hours
after the dose. Meals and beverages
were to be free of grapefruit products, xanthine, and caffeine and were to be
identical in each study period. There
was to be at least a 3-week washout period between study periods.
74
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