Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers (CRC-C1721)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483259
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : November 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

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.

Condition or disease Intervention/treatment Phase
Relative Bioavailability Drug: Sulfatinib T capsule Drug: Sulfatinib R capsule Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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) .
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers in Chinese Adult Male Healthy Volunteers
Actual Study Start Date : April 2, 2018
Actual Primary Completion Date : May 12, 2018
Actual Study Completion Date : May 18, 2018

Arm Intervention/treatment
Experimental: Arm A-Sulfatinib T capsule
The subjects in this arm will receive sulfatinib T capsules from Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd.
Drug: Sulfatinib T capsule
Sulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production.
Other Name: HMPL-012, Surufatinib

Experimental: Arm B-Sulfatinib R capsule
The subjects in this arm will receive sulfatinib R capsules from Beijing Yiling Bioengineering Technology Co., Ltd.
Drug: Sulfatinib R capsule
Sulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd.
Other Name: HMPL-012, Surufatinib




Primary Outcome Measures :
  1. The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of Sulfatinib [ Time Frame: 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.

  2. Maximum observed plasma concentration (Cmax) of Sulfatinib [ Time Frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5 ]
    Maximum observed concentration, occurring at Tmax.

  3. The time to Cmax (peak time, Tmax) of Sulfatinib [ Time Frame: 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.

  4. Half-life (t1/2) of Sulfatinib [ Time Frame: 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.

  5. Relative Bioavailability [ Time Frame: 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 Outcome Measures :
  1. Adverse Event (AE) monitoring of Sulfatinib [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483259


Locations
Layout table for location information
China, Shanghai
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai, China, 200031
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
Layout table for investigator information
Principal Investigator: Liu Yanmei, Master Shanghai Xuhui District Central Hospital

Layout table for additonal information
Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT03483259    
Other Study ID Numbers: 2016-012-00CH2
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: November 13, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hutchison Medipharma Limited:
Pharmacokinetics
Relative bioavailability