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
Overview
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Hutchison Medipharma Limited
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- time to maximum plasma concentration (Tmax)
Overview
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.
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects can communicate well with investigators, must be voluntary and sign the ICF, and agree to comply with the requirements in the study protocol;
- •Healthy male and female subjects aged 18-55 years (inclusive);
- •Weight ≥50 kg, Body Mass Index (BMI) between 19-26 kg/m2 (inclusive);
- •Subjects with good health condition
- •Subjects of childbearing potential must promise to use reliable contraceptive measures.
Exclusion Criteria
- •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);
- •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;
- •History of gastrointestinal surgery, kidney surgery, cholecystectomy and other surgeries that might affect drug absorption or excretion judged by the investigator;
- •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;
- •Previous history of hypertension;
- •Systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
- •Female subjects who have a positive pregnancy test;
- •Subjects who smoked \>10 cigarettes per day within 3 months prior to screening, or are unable to quit smoking completely during the study;
- •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);
- •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);
Arms & Interventions
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
Intervention: HMPL-523 (Drug)
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
Intervention: HMPL-523 (Drug)
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
Intervention: HMPL-523 (Drug)
Outcomes
Primary Outcomes
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
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
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
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
Secondary Outcomes
- Ratio between AUCs of two HMPL-523 Tablets(through study completion, an average of 2 months)
- safety information/AE,SAE(through study completion, an average of 2 months)