Visanne (Dienogest 2 mg) tablets (Reference Product)

Variable

Arithmetic

Mean

SD

CV%

Min

Median

Max

Primary Variable

C_max (ng/mL)

55.0587

12.02436

21.8

39.105

51.127

78.118

AUC_0−t (hr*ng/mL)

694.8138

194.88638

28.0

408.241

696.563

1100.844

AUC_0−∞ (hr*ng/mL)

727.4534

203.11283

27.9

434.141

729.589

1162.059

T_max (hr)

1.6346

0.93883

57.4

0.750

1.250

4.000

AUC_% Extrap_obs (%)

4.5198

1.37358

30.4

1.945

4.527

6.452

T_½ (hr)

12.8260

3.04074

23.7

8.436

12.320

17.699

Kel (hr⁻¹)

0.0570

0.01379

24.2

0.039

0.056

0.082

Dienogest 2 mg Tablets (Test Product)

Secondary Variable

C_max (ng/mL)

52.9390

13.48170

25.5

35.817

51.465

89.783

AUC_0−t (hr*ng/mL)

707.0434

186.81099

26.4

440.166

736.734

1007.867

AUC_0−∞ (hr*ng/mL)

738.9579

194.24527

26.3

459.597

768.867

1041.096

T_max (hr)

2.0192

0.59039

29.2

1.000

2.000

3.000

AUC_% Extrap_obs (%)

4.3629

1.08353

24.8

2.899

4.179

5.932

T½ (hr)

12.6727

2.63849

20.8

9.594

11.491

17.078

Kel (hr⁻¹)

0.0568

0.01095

19.3

0.041

0.060

0.072