Bioequivalence Study of 1 mg Glimepiride Tablet Manufactured by PT Hexpharm Jaya in Comparison with 1 mg Amaryl® Tablet Manufactured by PT Aventis Indonesia Pharma, Indonesia.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-0PPB91L
Tanggal Input Registry : 15-11-2023

30-06-2023
Cmax and AUCt
 
Bioequivalence Study of 1 mg Glimepiride Tablet Manufactured by PT Hexpharm Jaya in Comparison with 1 mg Amaryl® Tablet Manufactured by PT Aventis Indonesia Pharma, Indonesia.
Bioequivalence Study of 1 mg Glimepiride Tablet Manufactured by PT Hexpharm Jaya in Comparison with 1 mg Amaryl® Tablet Manufactured by PT Aventis Indonesia Pharma, Indonesia.
Interventional
1 mg Glimepiride Tablet
36
 

Inclusion Criteria:

Subjects had read the subject information and signed informed consent documents, Subjects healthy male and female, Subjects age range from 18 – 55 years, Subjects’ body mass index between 18 – 25 kg/m2, Subjects had a normal electrocardiogram, Subjects had the 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, Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening, Subjects accepted to use contraceptives (condom) before any intercourse with their spouse throughout the study

Exclusion Criteria:

Those who were pregnant and/or nursing women, Those with history of contraindication or hypersensitivity to glimepiride, or other antidiabetic agent, or other ingredients in the study products, or a history of serious allergic reaction to any drug, a significant allergic disease or allergic reaction, 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 and cardiovascular disease, Those with history or presence of any coagulation disorder or clinically significant hematology abnormalities, 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, Those who had participated in any clinical study within 3 months prior to the study (
 
KET-422/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
707/STD/PML/2022
Nabila Mudin Sutanto