Relative Bioavailability
Conditions
Keywords
Pharmacokinetics, Relative bioavailability
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 different manufacturers after breakfast. All subjects are required to collect PK blood samples before and after administration at the following time points: within 1 hour before administration, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours after administration (16 times point), each collection of venous blood is 2mL.
Interventions
DRUGSulfatinib T capsule
Sulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production.
DRUGSulfatinib R capsule
Sulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd.
Sponsors
Hutchison Medipharma Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Eligible subjects who did not meet the exclusion criteria were randomly assigned to one of the three groups: group A, B, and C (administration TRR, RTR and RRT, 9 subjects in each group, where T is the test formulation and R is the reference formulation) .
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects must be voluntary and sign an informed consent form and agree to comply with the requirements of the protocol； 2. Age of 18-40 (inclusive), male healthy volunteers； 3. Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as normal or abnormal but not clinically significant by investigators; 4. Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as normal or abnormal but not clinically significant by investigators; 5. Men whose partners are women of childbearing potential are required to use adequate contraceptive methods during participation in this study；
Exclusion criteria
1. 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; 2. Previous gastrointestinal surgery, kidney surgery, cholecystectomy and surgery history may affect the absorption or excretion of drugs; 3. Hypertension: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg; 4. Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) test positive, HIV or treponema pallidum antibodies test positive; 5. Any drugs that may change the liver and kidney clearance; 6. 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; 7. 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; 8. Any history of clinically serious disease or condition that the investigator believes may affect the outcome of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of Sulfatinib | Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5 | The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration. |
| Maximum observed plasma concentration (Cmax) of Sulfatinib | Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5 | Maximum observed concentration, occurring at Tmax. |
| The time to Cmax (peak time, Tmax) of Sulfatinib | Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5 | The time at which maximum plasma concentration (Cmax) is observed. |
| Half-life (t1/2) of Sulfatinib | Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5 | The time required for the concentration of the drug to reach half of its original value. |
| Relative Bioavailability | Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5 | This term represents the relationship between the bioavailability of a substance in two different media. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event (AE) monitoring of Sulfatinib | Measured from the date signed ICF to within 14 days after the last dose | AE monitoring will be assessed by incidence of AEs, AE grading, serious AEs, as well as laboratory determinations and vital sign parameters. |
Countries
China
Outcome results
None listed