Bioequivalence study of Telmisartan 80 mg caplet manufactured by PT Lapi Laboratories in comparison with Telmisartan 80 mg, Micardis tablet manufacutred by Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim am Rhein, Germany; for Boehringer Ingelheim Pharma GmbH, Ingelhaim am Rhein, Germany; imported by PT Boehringer Ingelheim Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Biometrik Riset Indonesia Laboratorium Medik Westerindo Rumah Sakit Siloam Kelapa Dua
No Registry
INA-F8CA5QT
Tanggal Input Registry : 22-08-2023

09-06-2022
Cmax, AUC
 
Bioequivalence study of Telmisartan 80 mg caplet manufactured by PT Lapi Laboratories in comparison with Telmisartan 80 mg, Micardis tablet manufacutred by Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim am Rhein, Germany; for Boehringer Ingelheim Pharma GmbH, Ingelhaim am Rhein, Germany; imported by PT Boehringer Ingelheim Indonesia
Bioequivalence study of Telmisartan 80 mg caplet manufactured by PT Lapi Laboratories in comparison with Telmisartan 80 mg, Micardis tablet manufacutred by Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim am Rhein, Germany; for Boehringer Ingelheim Pharma GmbH, Ingelhaim am Rhein, Germany; imported by PT Boehringer Ingelheim Indonesia
Interventional
Telmisartan
28
 

Inclusion Criteria:

a. Willing to participate and agree to sign the informed consent and communicate well with the investigators. b. Healthy female/male subjects as determined by the medical screening assessments. c. Aged 18 - 55 years inclusive. d. Body mass index within the range of 18.00 - 25.00 kg/m2. e. Vital signs, after 10 minutes resting, within the following ranges: (i). Pulse rate: 60 - 90 bpm. (ii). Respiratory rate : 12 – 20 x/minutes. (iii). Systolic blood pressure: 100 - 130 mmHg. (iv). Diastolic blood pressure: 60 - 90 mmHg. f. Have 12-lead ECG without significant abnormalities. g. Negative results of rapid test antigen Covid-19 in the screening process.

Exclusion Criteria:

a. Participate in another study within 3 (three) months before the first day of study drug administration. b. Pregnant or lactating female (urinary pregnancy test will be performed on screening day and prior study drug administrations on each period). c. Smoker or smoking more than 10 (ten) cigarettes per day. d. Intake of any prescription drug or non-prescription drug within 7 days before the first day of drug administration of this study. e. Blood donation or blood loss of 300 mL (or more) within 3 (three) months before the first day of study drug administration. f. History of drug and/or alcohol abuse or dependency within 12 months before the first day of study drug administration. g. Known hypersensitivity or contraindication to the study drug. h. Any surgical or medical condition (present or history) that might significantly alter the study's absorption, distribution, metabolism, or excretion, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. i. History of any bleeding or coagulative disorders. j. Clinically significant hematology abnormalities. k. Clinically significant urinalysis abnormalities. l. Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL). m. History or presence of any liver dysfunction (SGPT, alkaline phosphate, total bilirubin ≥ 1.5 ULN). n. Positive result of HBsAg, HCV, and/or HIV test.
 
KET-550/UN2.FI/ETIK/PPM.00.02/2021
Not applicable
PPUK/PPUB number
Ardani