BIOEQUIVALENCE STUDY OF GLIBENCLAMIDE 5 MG TABLET (LATIBET® 5 TABLET) PRODUCED BY PT IFARS PHARMACEUTICAL LABORATORIES WITH THE COMPARATOR DRUG (DAONIL® 5 MG TABLET, PT AVENTIS PHARMA, INDONESIA)

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-FQ206
Tanggal Input Registry : 02-01-2023

10-05-2022
Pharmacokinetic of AUC0-t dan Cmax
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BIOEQUIVALENCE STUDY OF GLIBENCLAMIDE 5 MG TABLET (LATIBET® 5 TABLET) PRODUCED BY PT IFARS PHARMACEUTICAL LABORATORIES WITH THE COMPARATOR DRUG (DAONIL® 5 MG TABLET, PT AVENTIS PHARMA, INDONESIA)
BIOEQUIVALENCE STUDY OF GLIBENCLAMIDE 5 MG TABLET (LATIBET® 5 TABLET) PRODUCED BY PT IFARS PHARMACEUTICAL LABORATORIES WITH THE COMPARATOR DRUG (DAONIL® 5 MG TABLET, PT AVENTIS PHARMA, INDONESIA)
Eksperimental
The participating subjects were given orally one film-coated tablet of the test drug (glibenclamide 5 mg tablet (Latibet® 5 Tablet) produced by PT IFARS Pharmaceutical Laboratories) and one film coated tablet of the comparator drug (Daonil® 5 mg Tablet, PT Aventis Pharma, Indonesia) after an overnight fast with 240 mL of 20% glucose solution in water according to the predetermined sequence.
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Inclusion Criteria:

Able to participate, communicate well with the investigators and would provide written informed consent to participate in the study; Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during the screening and could be considered healthy based on the evaluation; Aged 18-55 years inclusive; Preferably non-smokers or smoke less than 10 cigarettes per day; Body mass index within 18 to 25 kg/m2; Vital signs (after 10 minutes rest) were within the following range: Systolic blood pressure: 100 – 129 mmHg, Diastolic blood pressure: 60 – 84 mmHg, and Pulse rate: 60 – 90 bpm; and Willing to practice abstention or contraception during the study.

Exclusion Criteria:

History of allergy or hypersensitivity or contraindication to glibenclamide or other sulfonylurea or allied drugs; Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug); Any major illness in the past 90 days or clinically significant on going chronic medical illness; Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc; Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV; Positive result for COVID-19 antigen rapid test; Clinically significant hematology abnormalities; Clinically significant electrocardiogram (ECG) abnormalities; Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery; Past history of anaphylaxis or angioedema; History of drug or alcohol abuse within 12 months prior to screening for this study; Participation in any clinical trial within the past 90 days calculated from the last visit to this study’s first dosing day; History of any bleeding or coagulative disorders; Presence of difficulty in accessibility of veins in left or right arm; A donation or significant blood loss within 90 days before this study’s first dosing day; and Intake of any prescription drug (especially sulfonylurea), non prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day.
 
KET-239/UN2.F1/ETIK/PPM.00.02/2022
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Persetujuan Protokol Uji Bioekivalensi Nomor : RG.01.02.321.04.22.00872/UB
BE. 449/EQL/2017
Ronal Simanjuntak