A Drug-Drug Interaction Study Between HS-10374 Tablets and Drospirenone and Ethinyl Estradiol Tablets(Yasmin®)

NCT07181343 | Completed Phase 1

• 1 other identifier: HS-10374-118
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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®)

Conditions

Psoriasis (PsO)

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (14)

• Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Tmax

  up to Day 20

• Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: t1/2z

  up to Day 20

• Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: λz

  up to Day 20

• Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: CLz/F

  up to Day 20

• Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Vz/F

  up to Day 20

Study Arms (1)

HS-10374 + Drospirenone and Ethinyl Estradiol

EXPERIMENTAL

Drug: HS-10374 tablets; Drug: Drospirenone and Ethinyl Estradiol tablets

Interventions

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

HS-10374 + Drospirenone and Ethinyl Estradiol

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.

HS-10374 + Drospirenone and Ethinyl Estradiol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who sign the informed consent form before the trial, fully understand the trial content, procedures, and potential adverse reactions, and voluntarily commit to complying with all trial requirements.
• Healthy female participants aged 18 to 40 years (inclusive), with age calculated based on the date of signing the informed consent.
• Participants weighing ≥45 kg, with a body mass index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive). BMI = weight (kg) / height² (m²).
• Participants who agree to abstain from conception/donation of oocytes and practice complete abstinence from signing the informed consent until 40 days after the last dose.

You may not qualify if:

• Participants with clinically significant abnormalities in physical examination, vital signs, ECG, clinical laboratory tests, abdominal ultrasound, gynecological color ultrasound, or breast color Doppler ultrasound, as judged by the investigator.
• Positive results for any of the following during screening: Hepatitis B surface antigen (HBsAg), hepatitis C antibody, HIV antibody/p24 antigen, or Treponema pallidum antibody.
• Screening values exceeding 1.5×ULN for ALT, AST, or creatine kinase (CK), with clinical significance per investigator assessment.
• Screening serum creatinine \>1×ULN, judged clinically significant by the investigator.
• QT interval prolongation on 12-lead ECG during screening (QTcF ≥470 ms).
• History of myopathy or rhabdomyolysis.
• Severe pre-existing or current diseases affecting the nervous, psychiatric, digestive, circulatory, respiratory, urinary, cardiovascular, or immune systems-or any newly diagnosed condition prior to dosing-deemed by the investigator to contraindicate participation; including history of gastrointestinal disorders (e.g., gastric ulcer, reflux esophagitis).
• History of tuberculosis (TB).
• Current or previous history of: Venous thromboembolism (e.g., deep vein thrombosis, pulmonary embolism), Cerebrovascular disorders, Coronary artery disease, hypertension, Thrombogenic cardiac valvulopathy or rhythm disorders (e.g., subacute bacterial endocarditis with valvular disease, atrial fibrillation), Hereditary/acquired hypercoagulable states (e.g., Factor V Leiden mutation family history), Diabetes with vascular complications, Headaches with focal neurological symptoms, Migraine (with or without aura), Cholestatic jaundice and/or pruritus during prior hormone therapy.
• Current or previous renal impairment or adrenal insufficiency.
• Undiagnosed abnormal uterine/vaginal bleeding.
• Current or previous estrogen/progestin-sensitive cancers (e.g., breast cancer).
• Benign/malignant liver tumors or severe liver disease with safety risks per investigator judgment.
• Severe infections ≤30 days before screening (e.g., cellulitis, pneumonia, sepsis) OR herpes zoster within 3 months prior.
• Participants who have undergone surgery affecting drug absorption, distribution, metabolism, or excretion, deemed ineligible by the investigator.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266001, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

drospirenone; Ethinyl Estradiol

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 18, 2025
• Study Start: May 28, 2025
• Primary Completion: June 17, 2025
• Study Completion: August 19, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

CN (1)