Trials / Completed
CompletedNCT07181343
A Drug-Drug Interaction Study Between HS-10374 Tablets and Drospirenone and Ethinyl Estradiol Tablets(Yasmin®)
A Study to Evaluate the Pharmacokinetics of Drospirenone and Ethinyl Estradiol Tablets (Yasmin®) When Co-administered With HS-10374 Tablets
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Hansoh BioMedical R&D Company · Industry
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
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®)
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HS-10374 tablets | From Day 8 to Day 19, participants will orally take HS-10374 Tablets 12 mg(6 mg×2) once daily under fasting conditions |
| DRUG | Drospirenone and Ethinyl Estradiol tablets | On Day 1 and Day 14, participants will orally take one tablet of Drospirenone and Ethinylestradiol Tablets under fasting conditions. |
Timeline
- Start date
- 2025-05-28
- Primary completion
- 2025-06-17
- Completion
- 2025-08-19
- First posted
- 2025-09-18
- Last updated
- 2025-09-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07181343. Inclusion in this directory is not an endorsement.