Status:
COMPLETED
A Food-Effect Study of BPI-16350 in Healthy Subjects
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350. Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose of BPI-16350 o...
Eligibility Criteria
Inclusion
- Healthy subjects aged 18\~45 (including 18 and 45 years old);
- Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 \~ 26kg /m2;
- Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
- The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion；
- Able to comprehend and willing to sign an informed consent form.
Exclusion
- History of significant hypersensitivity to any drug compound or food；
- Significant history or clinical manifestation of any significant cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, musculoskeletal,hematological disorder；
- Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody is positive；
- Family history of long QTc syndrome; History or presence of an abnormal ECG；
- Drug abusers, smokers or alcoholics；
- Use of any medications within 14 days prior to the first administration；
- Donation of blood ≥ 200 mL or receipt of blood products within 3 months before enrollment, or plan on blood donation during the study period；
- Participation in any other investigational drug study or receive any vaccine within 3 months before enrollment；
- Female subjects who are pregnant or lactating；the serum HCG test of women with fertility is postive at Screening.
Key Trial Info
Start Date :
April 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05316259
Start Date
April 15 2022
End Date
August 30 2022
Last Update
May 9 2023
Active Locations (1)
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1
Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100069