Bioequivalence Study of 10 mg Lisinopril Dihydrate Tablets Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Zestril® 10 mg Tablets Manufactured by AstraZeneca Pharmaceutical Co., Ltd., China, Imported by the Marketing Authorization Holder AstraZeneca Pharmaceuticals (Phils.), Inc., Philippines

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
INA-KOPKZN8
Tanggal Input Registry : 24-04-2024

27-02-2023
AUC0-t , Cmax
AUC0-inf , Tmax, Half life
 
Bioequivalence Study of 10 mg Lisinopril Dihydrate Tablets Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Zestril® 10 mg Tablets Manufactured by AstraZeneca Pharmaceutical Co., Ltd., China, Imported by the Marketing Authorization Holder AstraZeneca Pharmaceuticals (Phils.), Inc., Philippines
Bioequivalence Study of 10 mg Lisinopril Dihydrate Tablets Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Zestril® 10 mg Tablets Manufactured by AstraZeneca Pharmaceutical Co., Ltd., China, Imported by the Marketing Authorization Holder AstraZeneca Pharmaceuticals (Phils.), Inc., Philippines
Interventional
Lisinopril Dihydrate 10 mg Tablets manufactured by PT Etercon Pharma for PT Novell Pharmaceutical Lab
28
 

Inclusion Criteria:

1. Gave a written informed consent. 2. Healthy subjects, both sexes, age between 18 to 55 years old. 3. Weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2). 4. Accepted normal values of blood pressure (systolic blood pressure 90 mmHg, diastolic blood pressure 60 mmHg) and heart rate (60-90 bpm). 5. Acceptable medical history and physical examination. 6. Normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR).* 7. Normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine.* 8. Normal urinalysis results including: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sediments (cells, casts, and bacteria).* 9. Normal cardiovascular function was proven by electrocardiogram (ECG) result. 10. Negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV). 11. Negative result for drug of abuse tests of amphetamine, metamphetamine, morphine, marijuana/tetrahydrocannabinol (THC), and benzodiazepine. 12. Negative result for pregnancy test (will be done screening, before period I and before period II of the study). 13. Negative result for rapid antigen test of COVID-19 (Coronavirus) during COVID-19 pandemic (were done for all subjects at screening). Note: * The clinical investigator might include a subject having value outside the accepted range, if in his/her opinion, these values were not clinically significant.

Exclusion Criteria:

1. Smoker. If necessary, light smoker (≤5 cigarettes/day) could be accepted. 2. Had history of hepatic, cardiovascular, gastrointestinal or renal disease. 3. Hypersensitivity to lisinopril or similar medication.(1) 4. Known allergy to ACE inhibitors.(1) 5. Had history of hereditary/idiopathic angioedema, or angioedema related to previous treatment with an ACE inhibitor.(1) 6. Pregnant, intended to become pregnant, or of childbearing potential who were not using adequate contraception.(1) 7. Nursing women.(1) 8. History of alcohol, drug abuse within 12 months prior to screening for this study. 9. Received any other medications within fourteen days prior to the start of the study. 10. Participated in any clinical study within 3 months prior the study. 11. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study.
 
KET-1066/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com