Bioequivalence Study of Xibertan® 300 Film-Coated Caplets (Irbesartan 300 mg) Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with Aprovel® 300 Film-Coated Tablets (Irbesartan 300 mg) 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-0BMOT1SW
Tanggal Input Registry : 08-05-2025

04-03-2024
Cmax and AUCt
 
Bioequivalence Study of Xibertan® 300 Film-Coated Caplets (Irbesartan 300 mg) Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with Aprovel® 300 Film-Coated Tablets (Irbesartan 300 mg) Manufactured by Sanofi Winthrop Industrie, France, Registered by PT Aventis Pharma, Indonesia
Bioequivalence Study of Xibertan® 300 Film-Coated Caplets (Irbesartan 300 mg) Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with Aprovel® 300 Film-Coated Tablets (Irbesartan 300 mg) Manufactured by Sanofi Winthrop Industrie, France, Registered by PT Aventis Pharma, Indonesia
Interventional
Xibertan® 300 film-coated caplet
20
 

Inclusion Criteria:

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

Exclusion Criteria:

pregnant and/or nursing condition, 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, significant allergic disease, or allergic reaction, 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 cardiovascular disease (myocarditis), history or presence of any coagulation disorder or clinically significant hematology abnormalities, disagree to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse from screening until 1 week after last dose of study drug, 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, participated in any clinical study within the past 90 days prior to the study, donated or lost 300 mL (or more) of blood within 3 months prior to the study, had smoking habit with more than 10 cigarettes a day, not receiving the complete primary SARS CoV-2 vaccine, positive result of for SARS CoV-2 antigen test (for those who has not received the first booster vaccine), history direct contact with a COVID-19 positive person in the subject’s neighborhood with in the last 14 days, 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, positive result for HIV, HbsAg, and HCV tests (to be kept confidential), had history of drug or alcohol abuse within 12 months prior to screening for this study, unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-1534/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
774/STD/PML/2023
Nabila Mudin S