Bioequivalence study of Fixed Dose Combination of Levodopa 100 mg and Benserazide 25 mg, Levoben Tablet manufactured by PT Mersifarma Tirmaku Mercusana in comparison with Levodopa 100 and Benserazide 25 mg, Madopar Tablets Distributed in Australia by Roche Products Pty Limited, Level 8, 30-34 Hickson Road Sydney NSW 2000

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Not applicable
No Registry
INA-MKKRG0A
Tanggal Input Registry : 15-08-2023

29-03-2023
Cmax, AUC, tmax
 
Bioequivalence study of Fixed Dose Combination of Levodopa 100 mg and Benserazide 25 mg, Levoben Tablet manufactured by PT Mersifarma Tirmaku Mercusana in comparison with Levodopa 100 and Benserazide 25 mg, Madopar Tablets Distributed in Australia by Roche Products Pty Limited, Level 8, 30-34 Hickson Road Sydney NSW 2000
Bioequivalence study of Fixed Dose Combination of Levodopa 100 mg and Benserazide 25 mg, Levoben Tablet manufactured by PT Mersifarma Tirmaku Mercusana in comparison with Levodopa 100 and Benserazide 25 mg, Madopar Tablets Distributed in Australia by Roche Products Pty Limited, Level 8, 30-34 Hickson Road Sydney NSW 2000
Interventional
Not applicable
32
 

Inclusion Criteria:

Participating subjects will have to fulfill the following inclusion criteria: a. Willing to participate and agree to sign informed consent and communicate well with the investigators b. Healthy female/male subjects as determined by the medical screening assessments c. Aged 30 – 5 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 – 129 mmHg (iv) Diastolic blood pressure : 60 – 84 mmHg (v) Body temperature < 37.5 degree celcius f. Have 12-lead ECG without significant abnormalities g. Negative results of rapid test antigen Covid-19 at screening process

Exclusion Criteria:

Any of the following criteria will exclude the subject from the study: a. Participate in another study within 3 (three) months prior to 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 prior to the first day of drug administration of this study e. Blood donation or blood loss of 300 mL (or more) within 3 (three) months prior to the first day of study drug administration f. History of drug and/or alcohol abuse or dependency within 12 months prior to the first day of study drug administration g. Known hypersensitivy or contraindication to the study drug h. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery i. History of any bleeding or coagulative disorders j. The Present/History of Precious phychiatric disorders k. Clinically significant hematology abnormalities l. Clinically significant urinalysis abnormalities m. Renal insuffiency (plasma’s creatinine concentration > 1.50 mg/dL) n. History or presence of any liver dysfunction (SGPT, SGOT, alkaline phosphate, total bilirubin ≥ 1.5 ULN) o. Positive result of HBsAg, HCV, and/or HIV test
 
S-156/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
apt. Erma Suryani, S.Si