Bioequivalence study of telmisartan 80 mg tablet produced by PT Amarox Pharma Global in comparison with the comparator drug (Micardis® 80 mg Tablet, Boehringer Ingelheim Pharma GmbH & Co. KG for Boehringer Ingelheim International GmbH, Germany, imported by PT Boehringer Ingelheim Indonesia, Bogor, Indonesia)

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-3GA758K
Tanggal Input Registry : 15-12-2023

01-08-2023
AUC0-72h dan Cmax
 
Bioequivalence study of telmisartan 80 mg tablet produced by PT Amarox Pharma Global in comparison with the comparator drug (Micardis® 80 mg Tablet, Boehringer Ingelheim Pharma GmbH & Co. KG for Boehringer Ingelheim International GmbH, Germany, imported by PT Boehringer Ingelheim Indonesia, Bogor, Indonesia)
Bioequivalence study of telmisartan 80 mg tablet produced by PT Amarox Pharma Global in comparison with the comparator drug (Micardis® 80 mg Tablet, Boehringer Ingelheim Pharma GmbH & Co. KG for Boehringer Ingelheim International GmbH, Germany, imported by PT Boehringer Ingelheim Indonesia, Bogor, Indonesia)
Interventional
The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one tablet of the test drug (telmisartan 80 mg tablet produced by PT Amarox Pharma Global) or one tablet of the comparator drug (Micardis® 80 mg Tablet, Boehringer Ingelheim Pharma GmbH & Co. KG for Boehringer Ingelheim International GmbH, Germany, imported by PT Boehringer Ingelheim Indonesia, Bogor, Indonesia) given with 200 mL of water and swallowed whole without chewing.
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Inclusion Criteria:

1. Able to participate, communicate well with the investigators and would provide written informed consent to participate in the study, 2. 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, 3. Aged 18-55 years inclusive, 4. Non-smokers, 5. Body mass index within 18 to 25 kg/m2, 6. Vital signs (after 10 minutes rest) were within the following ranges: • Systolic blood pressure : 110 – 129 mmHg • Diastolic blood pressure : 70 – 84 mmHg • Pulse rate : 60 – 90 bpm, 7. Having a normal value for liver function test (i.e., AST less than 35 IU/L; ALT less than 45 IU/L; AP 53-128 IU/L; total bilirubin less than 1.2 mg/dL; and direct bilirubin less than 0.50 mg/dL) 8. Willing to practice abstention or non-hormonal contraception during the study.

Exclusion Criteria:

1. History of allergy or hypersensitivity or contraindication to telmisartan or allied drugs, 2. Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug), 3. Any major illness in the past 90 days or clinically significant ongoing chronic medical illness, 4. 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), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc, 5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV, 6. Clinically significant hematology abnormalities, 7. Clinically significant electrocardiogram (ECG) abnormalities, 8. 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, 9.Past history of anaphylaxis or angioedema, 10.History of drug or alcohol abuse within 12 months prior to screening for this study, 11.Participation in any clinical trial within the past 90 days calculated from the last visit to this study’s first dosing day, 12.History of any bleeding or coagulative disorders, 13.Presence of difficulty in accessibility of veins in left or right arm, 14.A donation or significant blood loss within 90 days before this study’s first dosing day, 15.Intake of any prescription (especially telmisartan and irbesartan), non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day, 16. History or presence of hyperkalemia.
 
S-349/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
BE. 749/EQL/2022
Ronal Simanjuntak – PT Equilab International