Bioequivalence Study of 1 mg Glimepiride Tablets Produced by PT. Etercon Pharma in Comparison with Amaryl® 1 mg Tablets Manufactured by PT. Aventis Pharma, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
INA-71PYQSZT
Tanggal Input Registry : 17-09-2025

21-05-2025
AUC0-t , Cmax, AUC0-inf
Tmax, Half life
 
Bioequivalence Study of 1 mg Glimepiride Tablets Produced by PT. Etercon Pharma in Comparison with Amaryl® 1 mg Tablets Manufactured by PT. Aventis Pharma, Indonesia
Bioequivalence Study of 1 mg Glimepiride Tablets Produced by PT. Etercon Pharma in Comparison with Amaryl® 1 mg Tablets Manufactured by PT. Aventis Pharma, Indonesia
Interventional
Glimepiride 1 mg tablet manufactured by PT Etercon Pharma
24
 

Inclusion Criteria:

Gave a written informed consent, Healthy subjects, both sexes, age between 18 to 55 years old, Weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2), Accepted normal values of blood pressure (systolic blood pressure 91-129 mmHg and diastolic blood pressure 61-84 mmHg) and heart rate (60-90 bpm), Accepted normal values of body temperature (35.0-37.5°C) and respiration rate (12-20 breaths/min), Acceptable medical history and physical examination, Normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR), Normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine, Normal urinalysis results including: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sediments (cells, casts, and bacteria), Normal cardiovascular function was proven by electrocardiogram (ECG) result, Negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV), Negative result for drug of abuse tests of amphetamine, metamphetamine, morphine, marijuana/tetrahydrocannabinol (THC), and benzodiazepine (were done for all subjects at screening, before period I and before period II of the study), Negative result for pregnancy test (will be done for female subjects at screening, before period I and before period II of the study).

Exclusion Criteria:

Smoker. If necessary, light smoker (≤5 cigarettes/day) could be accepted, Pregnant women or nursing mother, Had history of hepatic, cardiovascular, gastrointestinal or renal disease, Had condition of insulin-dependent (type I) diabetes mellitus, diabetic ketoacidosis (with or without coma), or diabetic coma or precoma, Had condition of certain uncompensated disorders of the endocrine system affecting carbohydrate metabolism or counter-regulation of hypoglycaemia (as for example in certain disorders of thyroid function and in anterior pituitary or adrenocortical insufficiency), Had condition of certain type of nervous disease (autonomic neuropathy), Had condition of glucose-6-phosphate dehydrogenase (G6PD) deficiency, Hypersensitivity to glimepiride, other sulfonylureas, other sulfonamides, or similar medication. History of alcohol, drug abuse within 12 months prior to screening for this study, Received any other medications within fourteen days prior to the start of the study, Participated in any clinical study within 3 months after the date of completion, Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study,
 
KET-1521/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com