Bioequivalence Study of 160 mg Valsartan / 10 mg Amlodipine (Vamlopin ®) Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Exforge ®Film Coated Tablets (160 mg Valsartan / 10 mg Amlodipine) Manufactured by Novartis Farmaceutica SA, Spain for Novartis Pharma AG, Switzerland, Imported by PT. Novartis Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
INA E092TGE
Tanggal Input Registry : 01-03-2023

01-04-2022
The primary objective of this study was to establish the bioequivalence of 160 mg valsartan / 10 mg amlodipine (Vamlopin®) film coated tablets produced by PT. Novell Pharmaceutical Laboratories in comparison with Exforge® film coated tablets (160 mg valsartan / 10 mg amlodipine) manufactured by Novartis Farmaceutica SA, Spain for Novartis Pharma AG, Switzerland, imported by PT. Novartis Indonesia.
Tolerance assessment was not a major objective in this study. However, comparison of tolerance between the two products was a secondary objective. The criteria of safety would include any adverse reactions or significant abnormal laboratory values, or abnormal physical examinations or vital signs measurements recorded during the study. Any of these observations were documented in the subject’s Case Report Form (CRF).
 
Bioequivalence Study of 160 mg Valsartan / 10 mg Amlodipine (Vamlopin ®) Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Exforge ®Film Coated Tablets (160 mg Valsartan / 10 mg Amlodipine) Manufactured by Novartis Farmaceutica SA, Spain for Novartis Pharma AG, Switzerland, Imported by PT. Novartis Indonesia
Bioequivalence Study of 160 mg Valsartan / 10 mg Amlodipine (Vamlopin ®) Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Exforge ®Film Coated Tablets (160 mg Valsartan / 10 mg Amlodipine) Manufactured by Novartis Farmaceutica SA, Spain for Novartis Pharma AG, Switzerland, Imported by PT. Novartis Indonesia
Interventional
The reference drug was Exforge ® film-coated tablets (160 mg Valsartan / 10 mg Amlodipine), Batch Number BPV03; Manufacturing date March 2020; Expiry date February 2023; manufactured by Novartis Farmaceutica SA, Spain for Novartis Pharma AG, Switzerland, Imported by PT. Novarrtis Indonesia. The test drug was Vamlopin ® film-coated tablets (160 mg Valsartan / 10 mg Amlodipine), Batch Number D20G01; Manufacturing date July 2020; Expired Date July 2022; produced by PT Novell Pharmaceutical Laboratories. Each subject received a single oral dose of one film-coated tablet of 160 mg Valsartan/10 mg Amlodipin, either as test or reference formulation were given with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for at least 8 hours. Water intake was allowed except for one hour before and one hour after the dose
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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 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 at 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.** *The clinical investigator might include a subject having value outside the accepted range, if in his/her opinion, these values were not clinically significant ** The criterion is subject to change at any time according to regulation issued by regulator and/or government

Exclusion Criteria:

1. Smoker. If necessary, light smoker (≤5 cigarettes/day) can be accepted. 2. Pregnant woman or nursing mother. 3. Had history of hepatic, cardiovascular, gastrointestinal or renal disease. 4. Have history or condition of severe hepatic impairment, biliary cirrhosis, or cholestasis.(2,5) 5. Had history or condition of hereditary angioedema.(5) 6. Had history or condition of severe hypotension.(2) 7. Had history or condition of shock (including cardiogenic shock).(2) 8. Had history or condition of obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis).(2) 9. Had history or condition of haemodynamically unstable heart failure after acute myocardial infarction.(2) 10. Potentially sensitive to this type medication or hypersensitive to valsartan, amlodipine, or dihydropyridines derivatives.(2,5) 11. History of alcohol, drug abuse within 12 months prior to screening for this study. 12. Received any other medications within fourteen days prior to the start of the study. 13. Participated in any clinical study within 3 months after the date of completion. 14. Donation or loss more than 300 ml of blood within 3 months prior to the screening of the study. 15. Positive result for rapid antigen test of COVID-19 (Coronavirus) at screening, before starting period I or II.
 
KET-591/UN2.F1/ETIK/PPM.00.02/2021
CCCVIII/082-022/CL/2021
Edria Rasendriya