Status:
COMPLETED
A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study was to evaluate the pharmacokinetics and safety of SHR6390 at doses of 100 mg, 125 mg, and 150 mg after process modification in Chinese healthy volunteers. A single oral dose of SHR6390 was...
Eligibility Criteria
Inclusion
- Healthy Chinese male and female aged 18-45years with a minimum weight of 50 kg for male and 45 kg for female subjects and a body mass index (BMI) of 18-26 kg/m2 who provided written informed consent for participating in the study.
- Without history of cardiovascular, hepatic, kidney, pulmonary, endocrine, gastrointestinal, neurological, or psychiatric disease.
- No pregnancy plan during the trial or within 6 months after completion of the trial.
- Voluntarily signed the informed consent form and strictly adherence to the study protocol.
Exclusion
- vital signs, physical examination, 12-lead electrocardiogram, and laboratory examination had results of clinical significance.
- Hepatitis B and C, human immunodeficiency virus (HIV) and syphilis antibody positive;
- Any history of allergy, alcohol and drug abuse;
- blood donation, massive blood loss (≥400mL).
- Participated in other clinical trials within three months. (6) Severe infection or surgery four weeks prior to screening;
- use of any drug that inhibits or induces hepatic metabolizing enzymes four weeks prior to screening;
- use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health care products fourteen days prior to screening;
- A history of dysphagia, gastrointestinal ulcers, or any gastrointestinal disease that interferes with drug absorption.
Key Trial Info
Start Date :
June 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05354336
Start Date
June 13 2019
End Date
August 24 2019
Last Update
May 5 2022
Active Locations (1)
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1
Phase I Clinical Research Center
Qingdao, Shandong, China, 266003