Bioequivalence study of Levazide® tablet (100 mg Levodopa and 25 mg Benserazide HCL) produced by PT Pyridam Farma in comparison with Madopar® 125 mg T tablet (100 mg Levodopa and 25 mg Benserazide HCL) manufactured by Roche Pharma AG, 79630 Grenzach-Whylen

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-XLLSX2Z
Tanggal Input Registry : 19-04-2022

05-03-2022
AUC0-t dan Cmax
AUC0-∞, t1/2, dan tmax
 
Bioequivalence study of Levazide® tablet (100 mg Levodopa and 25 mg Benserazide HCL) produced by PT Pyridam Farma in comparison with Madopar® 125 mg T tablet (100 mg Levodopa and 25 mg Benserazide HCL) manufactured by Roche Pharma AG, 79630 Grenzach-Whylen
Bioequivalence study of Levazide® tablet (100 mg Levodopa and 25 mg Benserazide HCL) produced by PT Pyridam Farma in comparison with Madopar® 125 mg T tablet (100 mg Levodopa and 25 mg Benserazide HCL) manufactured by Roche Pharma AG, 79630 Grenzach-Whylen
Eksperimental
The reference drug was the market available Madopar® 125 mg T tabletten (100 mg Levodopa and 25 mg Benserazide HCL) manufactured by Roche Pharma AG, 79630 Grenzach-Whylen, batch number M3211M1, expiration date on December 2024. The test drug was Levazide® tablet (100 mg Levodopa and 25 mg Benserazide HCL) produced by PT Pyridam Farma, batch number PELEV001.02-05; manufacturing date on October 2021; expiration date on October 2023
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Inclusion Criteria:

- Willing to sign the informed consent, - Age 25 – 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 (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, 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:

- With history of hypersensitivity or contraindicated to Levodopa and Benserazide 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, - If the study is conducted in Covid-19 pandemic situation, the exclusions criteria bellow must be applied: a. Those with history of direct contact with Covid-19 positive person within last 14 days b. Those with history or present sore throat, fever (with temperature more than 37oC) or short of breath within last 14 days c. Those who are positive to Covid-19 antigen rapid test
 
KET-106/UN2.F1/ETIK/PPM.00.02/2022
NA
RG.01.02.321.02.22.00700/UB
138/FORM/OMF/2021
apt. Haranissa Dea Oktania