To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers

Relative Bioavailability Clinical Trial

— CRC-C1721  

Official title:

To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers in Chinese Adult Male Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483259
• Other study ID #: 2016-012-00CH2
• Status: Completed
• Phase: Phase 1
• Start date: April 2, 2018
• Est. completion date: May 18, 2018

Study information

• Verified date: November 2018
• Source: Hutchison Medipharma Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, randomized, open, single-dose, three-cycle cross-design study, which will be only enrolled Chinese male healthy volunteers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 18, 2018
• Est. primary completion date: May 12, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Relative Bioavailability

Intervention

Drug:
• Sulfatinib T capsule
Sulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production.
• Sulfatinib R capsule
Sulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd.

Locations

Country	Name	City	State
China	Shanghai Xuhui District Central Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hutchison Medipharma Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of Sulfatinib	The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.	Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Primary	Maximum observed plasma concentration (Cmax) of Sulfatinib	Maximum observed concentration, occurring at Tmax.	Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Primary	The time to Cmax (peak time, Tmax) of Sulfatinib	The time at which maximum plasma concentration (Cmax) is observed.	Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Primary	Half-life (t1/2) of Sulfatinib	The time required for the concentration of the drug to reach half of its original value.	Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Primary	Relative Bioavailability	This term represents the relationship between the bioavailability of a substance in two different media.	Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Secondary	Adverse Event (AE) monitoring of Sulfatinib	AE monitoring will be assessed by incidence of AEs, AE grading, serious AEs, as well as laboratory determinations and vital sign parameters.	Measured from the date signed ICF to within 14 days after the last dose