Bioequivalence Study of 2 mg Glimepiride Tablets Manufactured by PT. Interbat (Friladar® 2 Tablet) in Comparison with 2 mg Amaryl® Tablets Manufactured by PT. Aventis Pharma, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-EL4DB2H
Tanggal Input Registry : 20-09-2023

13-05-2022
Cmax, AUC0-t
 
Bioequivalence Study of 2 mg Glimepiride Tablets Manufactured by PT. Interbat (Friladar® 2 Tablet) in Comparison with 2 mg Amaryl® Tablets Manufactured by PT. Aventis Pharma, Indonesia
Bioequivalence Study of 2 mg Glimepiride Tablets Manufactured by PT. Interbat (Friladar® 2 Tablet) in Comparison with 2 mg Amaryl® Tablets Manufactured by PT. Aventis Pharma, Indonesia
Interventional
Glimepiride 2 mg tablets
24
 

Inclusion Criteria:

have read the subject information and signed the informed consent documents, healthy male or female, age 18 – 55 years, body mass index between 18 – 25 kg/m2, have a normal electrocardiogram, blood pressure within normal range (systolic 90 – 120 mmHg and diastolic 60 – 80 mmHg), heart rate within normal range (60 – 100 bpm), absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening, agree to use protection (condom) before any intercourse with their spouse during the study

Exclusion Criteria:

pregnant and/or nursing condition, a history of contraindication or hypersensitivity to glimepiride, or other antidiabetic agents, or other ingredients in the study products, or a history of serious allergic reaction to any drug, a significant allergic disease or allergic reaction, a history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease, a history or presence of any coagulation disorder or clinically significant hematology abnormalities, 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, have participated in any clinical study within 3 months prior to the study (< 90 days), have donated or lost 300 ml (or more) of blood within 3 months prior to the study, smoker, history of travelling to another city within the last 14 days, history of direct contact with a COVID-19 positive person in the subject’s neighborhood, history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days, positive to SARS CoV-2 antigen test, positive to HIV, HBsAg, and HCV tests (to be kept confidential), a 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-243/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
650/STD/PML/2021
Nabila Mudin Sutanto, Pharm