Bioequivalence Study Of Irbesartan 300 Mg Film-Coated Tablets Manufactured By Pt Kimia Farma Tbk In Comparison With Aprovel® 300 Mg Film-Coated Tablets Manufactured By Sanofi Winthrop Industrie, France, Registered By Pt Aventis Pharma, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-RQBA8G2
Tanggal Input Registry : 27-05-2024

18-10-2023
AUC0-t , Cmax
AUC0-inf , Tmax, Half life
 
Bioequivalence Study Of Irbesartan 300 Mg Film-Coated Tablets Manufactured By Pt Kimia Farma Tbk In Comparison With Aprovel® 300 Mg Film-Coated Tablets Manufactured By Sanofi Winthrop Industrie, France, Registered By Pt Aventis Pharma, Indonesia
Bioequivalence Study Of Irbesartan 300 Mg Film-Coated Tablets Manufactured By Pt Kimia Farma Tbk In Comparison With Aprovel® 300 Mg Film-Coated Tablets Manufactured By Sanofi Winthrop Industrie, France, Registered By Pt Aventis Pharma, Indonesia
Interventional
Irbesartan 300 mg film-coated tablet manufactured by PT Kimia Farma Tbk
28
 

Inclusion Criteria:

1. Subjects had read the subject information and able to give written informed consent for participation in the study and comply with the study protocol/procedures; 2. Subjects healthy male and female; 3. Subjects age range from 18 – 55 years; 4. Subjects’ body mass index between 18 – 25 kg/m2; 5. Subjects had a normal electrocardiogram; 6. Subjects had resting vital signs (after 10 – 15 minutes of resting) were within the following range : Systolic blood pressure: 110 – 129 mmHg, Diastolic blood pressure: 70 – 84 mmHg, Pulse/Heart rate: 60 – 100 beats per minute; 7. Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion Criteria:

1. those who were pregnant and/or nursing condition; 2. those with a history of hypersensitivity or contraindication to irbesartan, 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. those with a history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric/intestine surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease (myocarditis); 4. those who had history or presence of any coagulation disorder or clinically significant hematology abnormalities; 5. those who disagreed to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse from screening until 1 week after last dose of study drug; 6. those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day; 7. those who had participated in any clinical study within the past 90 days prior to the study; 8. those who had donated or lost 300 mL (or more) of blood within 3 months prior to the study; 9. those who had smoking habit with more than 10 cigarettes a day; 10. those who not received the complete primary SARS CoV-2 vaccine; 11. those who had history of direct contact with a COVID-19 positive person in the subject’s neighborhood within the last 14 days; 12. those with a history or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea with in the last 14 days; 13. those who were positive result for HIV, HbsAg, and HCV tests (to be kept confidential); 14. those with a history of drug or alcohol abuse within 12 months prior to screening for this study; 15. those who were unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-1149/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Nabila, PT Pharma Metric Labs, email : nabila.pmlabs@gmail.com, Tel : +62 21 4265310