Bioequivalence Study of 0.25 mg Pramipexole Dihydrochloride Monohydrate (Pramivex®) Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Sifrol® 0.25 mg Tablets Manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany, Imported by PT. Boehringer Ingelheim, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
INA-SGW0RQP
Tanggal Input Registry : 28-03-2024

10-10-2023
AUC0-t , Cmax
AUC0-t , Cmax
 
Bioequivalence Study of 0.25 mg Pramipexole Dihydrochloride Monohydrate (Pramivex®) Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Sifrol® 0.25 mg Tablets Manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany, Imported by PT. Boehringer Ingelheim, Indonesia
Bioequivalence Study of 0.25 mg Pramipexole Dihydrochloride Monohydrate (Pramivex®) Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Sifrol® 0.25 mg Tablets Manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany, Imported by PT. Boehringer Ingelheim, Indonesia
Interventional
Pramivex 0,25 tablet manufactured by PT Novell Pharmaceutical Laboratories
18000
 

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 70 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 for female subjects at screening, before period I and before period II of the study). 13. Subject had either received COVID-19 (Coronavirus) vaccine minimum of first booster or negative result for rapid antigen test of COVID-19 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. Pregnant women or nursing mother. 3. Had history of hepatic, cardiovascular, gastrointestinal or renal disease. 4. Had a history or condition of postural/orthostatic hypotension.(1,3) 5. Had history or condition of hallucinations, abnormal behavior, and psychotic disorder.(1,2,3) 6. Had history or condition of dyskinesia.(1,2,3) 7. Had history or condition of dystonia.(1,2,3) 8. Had history or condition of rhabdomyolysis.(3) 9. Had history or condition of melanoma.(1,3) 10. Had history or condition of augmentation.(1,2,3) 11. Hypersensitivity to pramipexole dihydrochloride monohydrate or similar medication.(1,2,3) 12. History of alcohol, drug abuse within 12 months prior to screening for this study. 13. Received any other medications within fourteen days prior to the start of the study. 14. Participated in any clinical study within 3 months after the date of completion. 15. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study. 16. Had symptoms related to COVID-19 (e.g. fever, cough, cold, sore throat, or anosmia) or close contact with COVID-19 patients within fourteen days prior to the start of the study.
 
KET-541/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Apt. Windy Lusthom, S.Si – Study Director