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Trial record 1 of 10 for:    HMPL-523
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A Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers

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ClinicalTrials.gov Identifier: NCT05318820
Recruitment Status : Not yet recruiting
First Posted : April 8, 2022
Last Update Posted : April 8, 2022
Sponsor:
Information provided by (Responsible Party):
Hutchmed ( Hutchison Medipharma Limited )

Brief Summary:
This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Subject Drug: HMPL-523 Early Phase 1

Detailed Description:

This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects. This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).

The study includes three periods expected to last for 2 months: screening period, treatment period (for three cycles), and follow-up period

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects. This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase I Monocentric, Open-label, Randomized, Crossover Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers in Healthy Chinese Subjects
Estimated Study Start Date : April 2022
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : August 2022

Arm Intervention/treatment
Experimental: HMPL-523-TRR
Three cycle dose: TRR Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA
Drug: HMPL-523
This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).

Experimental: HMPL-523-RTR
Three cycle dose:RTR Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA
Drug: HMPL-523
This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).

Experimental: HMPL-523-RRT
Three cycle dose:RRT Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA
Drug: HMPL-523
This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).




Primary Outcome Measures :
  1. maximum plasma concentration (Cmax) [ Time Frame: through study completion, an average of 2 months ]
    To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects

  2. time to maximum plasma concentration (Tmax) [ Time Frame: Time Frame: through study completion, an average of 2 months ]
    To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects

  3. terminal elimination half-life (t1/2) [ Time Frame: through study completion, an average of 2 months ]
    To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects

  4. Area under plasma drug concentration-time curve (AUC0-t, AUC0-∞) [ Time Frame: through study completion, an average of 2 months ]
    To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects


Secondary Outcome Measures :
  1. Ratio between AUCs of two HMPL-523 Tablets [ Time Frame: through study completion, an average of 2 months ]
    To compare the relative bioavailability of HMPL-523 Tablet 300 mg (100 mg/tablet ×3) produced by two different manufacturers

  2. safety information/AE,SAE [ Time Frame: through study completion, an average of 2 months ]
    To observe the safety of HMPL-523 Tablet 300 mg (100 mg/tablet ×3) taken orally in a single dose after a standard meal in healthy Chinese subjects



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.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects can communicate well with investigators, must be voluntary and sign the ICF, and agree to comply with the requirements in the study protocol;
  2. Healthy male and female subjects aged 18-55 years (inclusive);
  3. Weight ≥50 kg, Body Mass Index (BMI) between 19-26 kg/m2 (inclusive);
  4. Subjects with good health condition
  5. Subjects of childbearing potential must promise to use reliable contraceptive measures.

Exclusion Criteria:

  1. History or clinical characterization of clinically significant metabolic/endocrine, hepatic, renal, hematological, pulmonary, immune, cardiovascular, gastrointestinal, genitourinary, neurological, or psychiatric diseases within 3 months prior to the screening period and in the screening period (judged by investigators);
  2. creatinine clearance estimated using Cockcroft-Gault formula [(140-age) × body weight (kg) × gender correction factor] /[0.818×Scr (umol/L)] (male: 1.00, female: 0.85) < 80 mL/min;
  3. History of gastrointestinal surgery, kidney surgery, cholecystectomy and other surgeries that might affect drug absorption or excretion judged by the investigator;
  4. History of serious allergy (e.g., drug allergy) and acute allergic rhinitis or food allergy, in particular allergy to the active ingredient or excipient of study drug, within two weeks prior to screening;
  5. Previous history of hypertension;
  6. Systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
  7. Female subjects who have a positive pregnancy test;
  8. Subjects who smoked >10 cigarettes per day within 3 months prior to screening, or are unable to quit smoking completely during the study;
  9. Subjects who drank on a regular basis within 6 months prior to the study, i.e., drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine);
  10. Subjects with drug abuse (including but not limited to Morphine, 3,4-methylenedioxy-methamphetamine (MDMA), methamphetamine, tetrahydrocannabinolic acid, Ketamine, Cocaine or subjects whose urine drug abuse screen showed positive);
  11. Use of blood products within 2 months before screening; donation of blood (including blood component) or loss of blood ≥400 mL within 3 months prior to screening, ≥200 mL within 1 month prior to screening, or plan to donate blood or blood component during the study or within 1 month after end of the study;
  12. Subjects who have a fear of needles, hemophobia or whose venous blood is hard to collect;
  13. Positive test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody;
  14. Use of any prescription drug and Chinese herbal tonic within 30 days prior to the first dose;
  15. Use of any over-the-counter drug (including but not limited to vitamins, prophylactic treatments, plant health products, etc.) within 14 days prior to the first dose;
  16. Having participated in clinical trials for other drugs/medical devices within 3 months prior to screening;
  17. Having consumed foods, juices and beverages containing alcohol, grapefruit, bigarade and caffeine within 72 hours prior to the first dose;
  18. Subjects vaccinated with a live-attenuated vaccine within 8 weeks prior to screening or planning to get vaccinated during participation of this clinical trial;
  19. Previous history of serious gastrointestinal disease, such as dysphagia, active gastric ulcer, inability to take drugs orally or absorption disorder for oral drugs;
  20. Subjects who have special requirements for diet and cannot comply with uniform diet;
  21. Lactating female subjects;
  22. According to the investigator's judgment, the subjects had any other disease or status that might affect the normal completion of the study or the evaluation of the study data, or had any other condition that was not suitable for the 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): NCT05318820


Contacts
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Contact: ailsa Xie 13825746813 ext 86 ailsax@hutch-med.com

Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Principal Investigator: Jingying Jia Shanghai Xuhui Central Hospital
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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT05318820    
Other Study ID Numbers: 2021-523-00CH1
First Posted: April 8, 2022    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No