Treating Pulmonary arterial hypertension (PAH) Bioequivalence Macitentan 10 mg Film-coated Tablets
Conditions
Interventions
The new generic products which were recently developed. Volunteer will receive a single dose of Macitentan 10 mg Film-coated with 250 mL of drinking water,The marketed original products which were al
Experimental Drug,Active Comparator Drug
Macitentan 10 mg Film-coated ,Reference Product
Sponsors
Bio-innova Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Thai male and female participants are between 18 to 55 years of age. 2. The BMI ranges from 18.5 to 25.0 kg/m2. 3. Comprehensive of the nature and purpose of the study, compliance with the requirements of the entire protocol and consent to blood collection by investigators of approximately 10 mL for screening process, and approximately 7 mL for monitoring participants safety after completion of the study. 4. Negative urine pregnancy test for women and no breast-feeding. 5. Absence of significant diseases or clinically significant abnormal laboratory values in the laboratory evaluations, medical history or surgery during the screening. Some laboratory values, for example complete blood count and others that are out of the normal range, will be carefully considered by physician.
Exclusion criteria
Exclusion criteria: 1. History or evidence of allergy or hypersensitivity to macitentan or any related drugs or any of the excipients of this product. 2. History or evidence of allergy or hypersensitivity to heparin. 3. Participant with a systolic BP <90 or >=140 mmHg, diastolic BP <60 or >=90 mmHg, and pulse rate >100 beats per minute. 4. Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).* 5. Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).* 6. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).* 7. Positive of hepatitis B and C virus. 8. Have more than one abnormal ECG, which is considered clinically significant.* 9. History of drug abuse. 10. History of alcoholism (more than 2 years). 11. History or evidence of any gastrointestinal disorder, previous gastrointestinal surgery other than appendectomy, hepatic, renal, cardiovascular, hematological or allergic disease, bronchial asthma, or any other disease that may affect the bioavailability of drug. 12. Any major illness in the past 3 months or any significant ongoing chronic medical illness. 13. History or evidence of psychiatric disorder. 14. History of regular alcohol consumption exceeding 7 drinks per week for females or 14 drinks per week for males (1 drink equals 5 ounces or 150 mL of wine, 12 ounces or 360 mL of beer, or 1.5 ounces or 45 mL of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study. 15. History of regular smoking (more than 10 cigarettes per day within the past 1 year), or moderate smoking (less than 10 cigarettes per day) if cannot stop at least 7 days before the study drug administration and until the completion of each period of the study. 16. High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop caffeine intake for at least 2 days before the study drug administration and until the completion of each period of the study. 17. Positive drug abuse test in urine (Marijuana (THC), Cocaine, Opioids Methamphetamine, and Benzodiazepines). 18. Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 7 days or hormonal methods of contraception within 28 days (Depo-Provera must be discontinued at least 6 months) prior to the study drug administration and until the completion of each period of the study. 19. History of difficulty in accessibility of veins in left and right arm. 20. Blood donation (one unit or 450 mL) within the past 3 months before the study. 21. Participation in any clinical study within the past 3 months before the study. 22. Participants who are unwilling or unable to comply with the lifestyle guidelines described in this protocol. *Depending on decision of principal investigator and/or clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Macitentan level pre-dose (0.00 hour) and at 1.00, 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 10.00, 11.00, 12.00, 24.00, 36.00, 48.00, and 72.00 hours Maximum plasma concentration, area under the plasma concentration curve from dosing to last observed concentration at time t, area under the plasma concentration curve extrapolated to infinite time | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital sign (Systolic BP, Diastolic BP, Pulse) at check-in, pre-dose, and at approximately 4, 8, 12, 24, 36, 48, and 72 hours post-dose Automatic blood pressure,Adverse event monitoring Reported by the participants or observed by the investigator clinical laboratory monitoring, physician decision | — |
Countries
Thailand
Contacts
Public ContactSasitorn Kittivoravitkul
Bio-innova Co., Ltd
Outcome results
None listed