Healthy
Conditions
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 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting conditions(Treatment A) or with a high-fat meal(Treatment B).
Interventions
DRUGBPI-16350
Administered orally
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose | Maximum observed concentration |
| AUC0-t | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose | Area under the concentration-time curve from time 0 to time t |
| AUC0-∞ | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose | Area under the concentration-time curve from time 0 to infinity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tlag | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose | Lag Time |
| AUC %Extrap | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose | Percentage of AUCinf due to extrapolation from Tlast to infinity |
| Tmax | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose | Time to reach maximum observed plasma concentration |
| V/F | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose | Apparent Volume of Distribution |
| Characterize the safety of BPI-16350 | from Day 1 to Day 23 | Number of subjects with treatment related adverse events |
| CL/F | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose | Apparent Oral Clearance |
| t1/2 | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose | Half-life time |
| λz | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose | Elimination rate constant |
Countries
China
Outcome results
None listed