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Completed

NCT Number: NCT03483259

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

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

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, 200031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Sulfatinib T capsule

Drug

Sulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production.

Other names: HMPL-012, Surufatinib

Sulfatinib R capsule

Drug

Sulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd.

Other names: HMPL-012, Surufatinib

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hutchison Medipharma Limited

Industry

Registry information

Official study title

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

Acronym: CRC-C1721

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 30, 2018
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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