Status:
COMPLETED
To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers
Lead Sponsor:
Hutchison Medipharma Limited
Conditions:
Relative Bioavailability
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
This is a single-center, randomized, open, single-dose, three-cycle cross-design study, which will be only enrolled Chinese male healthy volunteers.
Detailed Description
27-30 Chinese male healthy volunteers will be enrolled to assess the pharmacokinetic profile and relative bioavailability of 300 mg (50 mg x 6) Sulfatinib capsules of single dose orally in two differe...
Eligibility Criteria
Inclusion
- Subjects must be voluntary and sign an informed consent form and agree to comply with the requirements of the protocol；
- Age of 18-40 (inclusive), male healthy volunteers；
- Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as normal or abnormal but not clinically significant by investigators;
- Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as normal or abnormal but not clinically significant by investigators;
- Men whose partners are women of childbearing potential are required to use adequate contraceptive methods during participation in this study；
Exclusion
- Any clinically significant disease or condition includes but not limited to metabolism/endocrine, liver, kidney, blood, lung, immune, cardiovascular, gastrointestinal, genito-urinary, nervous, or mental illness that judged by the investigator within 3 months before screening;
- Previous gastrointestinal surgery, kidney surgery, cholecystectomy and surgery history may affect the absorption or excretion of drugs;
- Hypertension: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
- Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) test positive, HIV or treponema pallidum antibodies test positive;
- Any drugs that may change the liver and kidney clearance;
- Take any prescription drug (including Chinese herbal medicine) within 14 days before dosing; or use any over-the-counter drugs (including but not limited to vitamins, prophylaxis, plant health products) within 7 days before dosing;
- Clinical trials of other medications before screening, less than a 5-fold half-life or 28 days from the time of the last other study drug, whichever is longer;
- Any history of clinically serious disease or condition that the investigator believes may affect the outcome of this study.
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03483259
Start Date
April 2 2018
End Date
May 18 2018
Last Update
November 13 2018
Active Locations (1)
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1
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, China, 200031