6.2.4
BIOEQUIVALENCE
STUDY
A TWO-WAY, CROSSOVER, STEADY STATE, MULTIPLE-DOSE OPEN-LABEL FASTING COMPARATIVE BIOAVAILABILITY STUDY OF BUPROPION HCL 300 MG EXTENDED-RELEASE TABLETS (1X300 MG Q.D.) VERSUS WELLBUTRIN 100 MG TABLETS (TID) 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: AK1BIOVAIL2543
OBJECTIVES:
To
evaluate the bioavailability of a once-daily bupropion hydrochloride (HCl)
extended release tablet test formulation (1x300 mg q.d., Lot Number 01K211)
relative to reference WELLBUTRIN tablets (1x 100 mg tid) under steady-state,
fasting conditions.
FORMULATIONS:
Table
1. Products used in AK1BIOVAIL2543
|
|
Package
Lot Number |
Dose
Form Lot
Number |
Date
of Manufacture (Dates
of Study) |
|
Test Product (T) Bupropion
HCl 300 mg extended release tablets
(Biovail Corporation, USA) |
01K211 |
01K008 |
October
2001 (October
29, 2001 – December
10, 2001) |
|
Reference Product (R) WELLBUTRIN
100 mg tablets ([blacked
out] GlaxoSmithKline) |
1A2494 |
- |
Exp
Date 3/2003 |
The
batch size for the test product was [blacked out] tablets. This represents approximately [blacked
out] of the proposed commercial batch size of [blacked out]. Stability studies were ongoing at the time
of the review. According to the
Sponsor, the test product was stable for at least 9 months.
STUDY
DESIGN:
This
study was an open-label, randomized, 2-period, 2-treatment, 2-sequence
crossover multiple dose, steady-state study, as shown in Table 1, (Table 2), below.
For Treatment A, subjects received WELLBUTRIN 100 mg bid on day 1,2, and
3 (beginning at 7AM), and received bupropion 300 mg (extended release tablet)
daily on the mornings of Days 4 to 13 (treatment period T). For Treatment B, subjects received
WELLBUTRIN 100 mg bid (beginning at 7AM) on days 1, 2, and 3 and WELLBUTRIN 100
mg tid (at 0, 6, and 12 hours beginning at 7AM) on Days 4 to 13 (treatment
period R). There was a minimum interval
of 2 weeks between the last dose of Day 13
80
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