Parameter

Product

GM

GM, 95% CI

GMR (Test vs Reference), %

GMR, 90% CI

Pseudo Intraparticipant % CV^{b}


AUC_{0t}, ng.hour/mL

Test

200,000

184,000–217,000

108.01

105.08111.03

6.9


Reference

185,000

170,000–201,000







AUC_{0inf}, 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







C_{max}, 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
_{
0inf
} area under the curve from time zero to infinity, AUC
_{
0t
} 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

^{a}A 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 C_{max} value. In compliance with the protocol, the predose level was maintained in the pharmacokinetic analysis without baseline correction

^{b}Estimated based on the elements of the variancecovariance matrix as: CV(%) = 100*sqrt[(σA^{2} + σB^{2} − 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)