BIOEQUIVALENCE STUDY OF KETOPROFEN 100 MG SUPPOSITORIES MANUFACTURED BY PT COMBIPHAR IN COMPARISON WITH PROFENID® 100 MG SUPPOSITORIES MANUFACTURED BY PT AVENTIS PHARMA, INDONESIA

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-68LT8NW
Tanggal Input Registry : 26-07-2024

20-03-2024
AUC0-t , Cmax
AUC0-inf , Tmax, Half life
 
BIOEQUIVALENCE STUDY OF KETOPROFEN 100 MG SUPPOSITORIES MANUFACTURED BY PT COMBIPHAR IN COMPARISON WITH PROFENID® 100 MG SUPPOSITORIES MANUFACTURED BY PT AVENTIS PHARMA, INDONESIA
BIOEQUIVALENCE STUDY OF KETOPROFEN 100 MG SUPPOSITORIES MANUFACTURED BY PT COMBIPHAR IN COMPARISON WITH PROFENID® 100 MG SUPPOSITORIES MANUFACTURED BY PT AVENTIS PHARMA, INDONESIA
Interventional
Profecom 100 mg suppositories
36
 

Inclusion Criteria:

1. Have read the subject information and able to give written informed consent for participation in the study and comply with the study protocol/procedures. 2. Healthy male and female 3. Age between 18 – 55 years 4. Body Mass Index (BMI) between 18–25 kg/m2 5. Having a normal electrocardiogram 6. Resting vital signs (after 10 – 15 minutes of resting) are within the following ranges: - Systolic blood pressure: 90 – 129 mmHg - Diastolic blood pressure: 60 – 84 mmHg - Pulse/Heart rate: 60 – 100 beats per minute 7. Have no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. 8. Have received the complete primary SARS CoV-2 vaccine. 9. Negative result of SARS CoV-2 antigen test (for those who has not received the first booster vaccine).

Exclusion Criteria:

1. Pregnant and/or nursing woman. 2. Having history of hypersensitivity or contraindication to ketoprofen, or allied drugs, or other ingredients in the study products, or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction 3. Having history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, active peptic ulcer, diarrhea, gastric/intestinal surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease. 4. Having history or presence of any coagulation disorder or clinically significant hematology abnormalities. 5. Having history or presence of electrolyte imbalance. 6. Having history or presence of rectal prolapse or hemorrhoid or rectal/anal bleeding. 7. Disagree to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse throughout the study. 8. Using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within one week prior to the drug administration day. 9. Participate in any clinical study within the past 90 days prior to the study. 10. Having donation or losing 300 mL (or more) of blood within 3 months prior to the study. 11. Smoker. 12. History of direct contact with a COVID-19 positive person in the subject’s neighborhood within the last 14 days. 13. History or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea within the last 14 days. 14. Positive result for HIV, HBsAg, and HCV tests (to be kept confidential). 15. History of drug or alcohol abuse within 12 months prior to screening for this study. 16. Subjects who unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-1824/UN2.F1/ETIK/PPM.00.02/2023 and S-136/UN.F1/ETIK/PPM.002/2024
Not applicable
PPUK/PPUB number
Merry Christianie