|
Parameter
|
Product
|
GM
|
GM, 95% CI
|
GMR (Test vs Reference), %
|
GMR, 90% CI
|
Pseudo Intra-participant % CVb
|
|---|
|
AUC0-t, ng.hour/mL
|
Test
|
200,000
|
184,000–217,000
|
108.01
|
105.08-111.03
|
6.9
|
| |
Reference
|
185,000
|
170,000–201,000
|
-
|
-
|
-
|
|
AUC0-inf, ng.hour/mL
|
Test
|
244,000
|
219,000–272,000
|
106.12
|
102.62–109.75
|
8.4
|
| |
Reference
|
230,000
|
206,000–257,000
|
-
|
-
|
-
|
|
Cmax, ng/mL
|
Test
|
5,830
|
5,450–6,230
|
116.89
|
113.66–120.22
|
7.0
|
| |
Reference
|
4,990
|
4,680–5,320
|
-
|
-
|
-
|
-
AUC
0-inf
area under the curve from time zero to infinity, AUC
0-t
area under the curve from time zero to the time of the last measurable analyte concentration, C
max
maximum plasma analyte concentration, CI confidence interval, CV coefficient of variation, GM geometric mean, GMR geometric mean ratio
-
aA nonzero predose concentration level was obtained at the beginning of period 2 in one participant. However, the measured predose level was < 1% of the participant’s corresponding Cmax value. In compliance with the protocol, the predose level was maintained in the pharmacokinetic analysis without baseline correction
-
bEstimated based on the elements of the variance-covariance matrix as: CV(%) = 100*sqrt[(σA2 + σB2 − 2*σAB)/2], where A and B are the two treatments
- Test, PROGLICEM® 100 mg hard capsules, Batch No.: 3107A (Merck Sharp & Dohme Corp, USA); reference, PROGLYCEM® 100 mg capsules, Lot No.: 120118 (Merck Canada Inc., Canada)
