This trial is a single-center, open-label, fixed-sequence, self-controlled clinical study to evaluate Drug-Drug Interaction Between HS-10374 Tablets and Drospirenone and Ethinyl Estradiol Tablets (Yasmin®)
This trial is a single-center, open-label, fixed-sequence, self-controlled clinical study. On Day 1 and Day 14, participants will orally take one tablet of Drospirenone and Ethinylestradiol Tablets (containing Drospirenone 3 mg and Ethinylestradiol 0.03 mg) under fasting conditions. From Day 8 to Day 19, participants will orally take HS-10374 Tablets 12 mg once daily under fasting conditions. Both drugs should be administered with approximately 240 mL of water.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
18
From Day 8 to Day 19, participants will orally take HS-10374 Tablets 12 mg(6 mg×2) once daily under fasting conditions
On Day 1 and Day 14, participants will orally take one tablet of Drospirenone and Ethinylestradiol Tablets under fasting conditions.
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Cmax
Maximum concentration
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: AUC0-t
Area under the plasma concentration-time curve fom time 0 to last time of quantifiable concentration
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: AUC0-24 h
Area under the plasma concentration-time curve fom time 0 to 24 h of quantifiable concentration
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: AUC0-∞
Area under the plasma concentration-time curve from time 0 extrapolated to infinite time
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Tmax
Time to maximum concentration.
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: t1/2z
Elimination half-life
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: λz
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Elimination rate constant.
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: CLz/F
Plasma clearance.
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Vz/F
Apparent volume of distribution
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: MRT0-t
Mean Residence Time from 0-t
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: MRT0-∞
Mean Residence Time from 0-∞
Time frame: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing:Cmax
Maximum concentration
Time frame: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Cmin
Minimum concentration
Time frame: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Cav
Steady State Concentration
Time frame: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: AUC0-24h
Area under the plasma concentration-time curve fom time 0 to 24 h of quantifiable concentration
Time frame: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Tmax
Time to maximum concentration
Time frame: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: t1/2z
Elimination half-life
Time frame: up to Day 20
Evaluation of the safety after single oral administration of HS-10374 tablets and drospirenone/ethinylestradiol tablets in healthy participants
Frequency of Adverse Events
Time frame: through study completion, an average of 1 month