Healthy Subject Clinical Trial
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
Verified date | April 2023 |
Source | Hutchmed |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | September 30, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Xuhui Central Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Hutchison Medipharma Limited |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | maximum plasma concentration (Cmax) | 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 | through study completion, an average of 2 months | |
Primary | time to maximum plasma concentration (Tmax) | 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 | Time Frame: through study completion, an average of 2 months | |
Primary | terminal elimination half-life (t1/2) | 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 | through study completion, an average of 2 months | |
Primary | Area under plasma drug concentration-time curve (AUC0-t, AUC0-8) | 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 | through study completion, an average of 2 months | |
Secondary | Ratio between AUCs of two HMPL-523 Tablets | To compare the relative bioavailability of HMPL-523 Tablet 300 mg (100 mg/tablet ×3) produced by two different manufacturers | through study completion, an average of 2 months | |
Secondary | safety information/AE,SAE | 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 | through study completion, an average of 2 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02664883 -
Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer
|
||
Completed |
NCT05611281 -
GS3-007a Oral Solution in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03457480 -
Text Messages in Preventing Tobacco Use in Young Adults
|
N/A | |
Completed |
NCT05358756 -
A Study of Bioavailability and Food Effect of SACT-1 and Edurant® Tablets in Healthy Adult Volunteers
|
Phase 1 | |
Completed |
NCT06037395 -
Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
|
Phase 1 | |
Active, not recruiting |
NCT04032106 -
HPV Vaccine Intervention for Young Sexual Minority Men
|
N/A | |
Completed |
NCT04062955 -
Effects of Alternative Healthy Eating Index-Based Diet on Inflammatory Markers and Breast Density in Healthy Participants
|
N/A | |
Recruiting |
NCT03897270 -
Photoacoustic Imaging of the Breast in Patients With Breast Cancer and Healthy Subjects
|
N/A | |
Completed |
NCT01846520 -
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
|
N/A | |
Completed |
NCT02960100 -
mHealth Intervention in Increasing HPV Vaccinations in College Students
|
N/A | |
Completed |
NCT03698318 -
Pharmacokinetics Assessing Bioavailability of Gingerols and Shogaols of Five Ginger Extracts
|
N/A | |
Completed |
NCT05497635 -
A Study of STSA-1002 in Healthy Subjects
|
Phase 1 | |
Active, not recruiting |
NCT03303846 -
Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients
|
N/A | |
Terminated |
NCT05559125 -
A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03584100 -
Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal
|
N/A | |
Recruiting |
NCT05117385 -
The Effect of the Consumption of 4 Botanical Extracts on Immunity in Healthy Adults (B-4-Immune)
|
N/A | |
Active, not recruiting |
NCT05660720 -
Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT03188848 -
Dose Escalating Study of BPI-3016 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01908920 -
Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects
|
N/A | |
Active, not recruiting |
NCT03491176 -
Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer
|
N/A |