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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10374 + Drospirenone and Ethinyl Estradiol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10374 tablets | Drug | From Day 8 to Day 19, participants will orally take HS-10374 Tablets 12 mg(6 mg×2) once daily under fasting conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Cmax | Maximum concentration | 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 | 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 | 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 | up to Day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Tmax | Time to maximum concentration. | up to Day 20 |
| Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: t1/2z |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266001 | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C035144 | drospirenone |
| D004997 | Ethinyl Estradiol |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
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| Drospirenone and Ethinyl Estradiol tablets | Drug | On Day 1 and Day 14, participants will orally take one tablet of Drospirenone and Ethinylestradiol Tablets under fasting conditions. |
|
Elimination half-life |
| up to Day 20 |
| Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: λz | Elimination rate constant. | 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. | 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 | 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 | 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-∞ | up to Day 20 |
| Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing:Cmax | Maximum concentration | up to Day 20 |
| Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Cmin | Minimum concentration | up to Day 20 |
| Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Cav | Steady State Concentration | 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 | up to Day 20 |
| Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Tmax | Time to maximum concentration | up to Day 20 |
| Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: t1/2z | Elimination half-life | 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 | through study completion, an average of 1 month |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |