GEMFIBROZIL TABLETS USP
600 mg
COMPARATIVE
BIOAVAILABILITY
STUDY
APOTEX CORP.
Gemfibrozil Tablets USP
PRODUCT INFORMATION
Product:
Gemfibrozil Tablets USP 600 mg
Approval Date:
July 20, 1998
Indication:
Regulating agent which decreases serum triglycerides and very low density lipoprotein (VLDL) cholesterol and
increases high density lipoprotein (HDL) cholesterol.
Description:
White to off-white, oval, scored, film-coated tablets, imprinted “APO” bisect “034” on one side and “600” on the
other side.
COMPARATIVE FASTING BIOAVAILABILITY STUDY OF
APOTEX CORP. GEMFIBROZIL TABLETS USP 600 mg AND LOPID® PARKE-DAVIS, INC
Study Design:
Subjects:
Standard 2-way cross-over bioavailability study
Normal human volunteers
Number:
37
Sex:
Male
Mean Age:
34.8 years
Mean Weight:
171.7 lbs
Dose Administered:
Sampling At:
Assay Method:
600 mg
0, 0.5, 1, 1.33, 1.67, 2, 2.33,
2.67, 3, 3.5, 4, 5, 6, 7, 8, 9, 10
and 12 hours
HPLC
Washout Time:
One week
Gemfibrozil
Mean (Std. Dev.)
90% Confidence Intervals*
(test/reference)
Apotex Gemfibrozil
Lopid
AUC 0-inf (µg ● hr/mL)
86.89 (19.73)
85.69 (23.68)
0.99 – 1.06
AUC 0-T (µg ● hr/mL)
83.49 (18.95)
82.76 (21.79)
0.98 – 1.06
Cmax (µg/mL)
25.46 (6.147)
25.79 (7.402)
0.91 – 1.11
* based on ln-transformed data
Mean Gemfibrozil Plasma Concentrations
25
Apotex Gemfibrozil
Lopid
Plasma Conc. (µg/mL)
20
15
10
5
0
0
2
4
6
8
Time (hours)
10
12
14