BIOEQUIVALENCE STUDY OF NEBIVOLOL 5 MG TABLET PRODUCED BY PT YARINDO FARMATAMA IN COMPARISON WITH NEBILET (NEBIVOLOL 5 MG) TABLET MANUFACTURED BY BERLIN-CHEMIE AG, GERMANY, IMPORTED BY PT. MENARINI INDRIA LABORATORIES - INDONESIA

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-CY27H
Tanggal Input Registry : 24-02-2022

11-01-2022
NA
NA
 
BIOEQUIVALENCE STUDY OF NEBIVOLOL 5 MG TABLET PRODUCED BY PT YARINDO FARMATAMA IN COMPARISON WITH NEBILET (NEBIVOLOL 5 MG) TABLET MANUFACTURED BY BERLIN-CHEMIE AG, GERMANY, IMPORTED BY PT. MENARINI INDRIA LABORATORIES - INDONESIA
BIOEQUIVALENCE STUDY OF NEBIVOLOL 5 MG TABLET PRODUCED BY PT YARINDO FARMATAMA IN COMPARISON WITH NEBILET (NEBIVOLOL 5 MG) TABLET MANUFACTURED BY BERLIN-CHEMIE AG, GERMANY, IMPORTED BY PT. MENARINI INDRIA LABORATORIES - INDONESIA
Eksperimental
The reference drug was the market available Nebilet® 5 mg tablet produced by Berlin-Chemie AG, Germany, imported by PT. Menarini Indria Laboratories - Indonesia, batch number 02705B manufacturing date May 2020; expiration date May 2023. The test drug was Nebivolol 5 mg tablet produced by PT Yarindo Farmatama, batch number 13210621; manufacturing date June 2021; expiration date June 2023.
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Inclusion Criteria:

- Willing to sign the informed consent, - Age 18 – 55 years, - Body mass index between 18 – 25 kg/m2, - Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 6080 mmHg), heart rate 60 – 90 beats per minute, - Healthy male/female (healthy criteria is determined by normal values or if outside the normal range of values but no clinically significant effects based on doctors' justification on the result of laboratory test include routine hematology, liver function, renal function, fasting blood sugar and urinalysis; history of disease, and physical examination), - Show normal result or within the acceptance range (not clinically significant effect based on doctor’s justification) in the electrocardiography (ECG) test result.

Exclusion Criteria:

- Who is contraindicated or has history of hypersensitivity to Nebivolol or related drug - With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease, - Who are using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the dosing day. - Who have participated in any clinical study within 3 months prior the study. - Who have donated or lost 300 mL (or more) of blood within 3 months prior the study, - Who smoke more than 10 sticks of cigarettes a day, - Who have any bleeding or coagulation disorder, - Who indicate the positive result on test for HbsAg, Anti-HCV and anti-HIV. - With the history of alcohol and drug abuse - Pregnant or lactating women - Female subjects who give positive pregnancy test at pre-study examination - If the study is conducted in Covid-19 pandemic situation, the exclusions criteria bellow must be applied: a. Those with history of travelling to another city within last 14 days b. Those with history of direct contact with a Covid-19 positive person in the subject neighborhood c. Those with history or present sore throat, fever (with temperature more than 37oC) or short of breath within last 14 days d. Those who are positive to Covid-19 antigen rapid test
 
KET-1140/UN2.F1/ETIK/PPM.00.02/2021
NA
RG.01.02.321.12.21.00576/UB
134/FORM/OMF/2021
apt. Haranissa Dea Oktania