Bioequivalence study of pramipexole dihydrochloride monohydrate 0.75 mg extended release tablet produced by PT Darya-Varia Laboratoria Tbk. in comparison with the comparator drug (Sifrol® ER 0.75 mg Extended Release Tablet produced by Boehringer Ingelheim Pharma GmbH & Co. KG, Germany, for Boehringer Ingelheim International GmbH, Germany, imported by PT Boehringer Ingelheim Indonesia, Indonesia)

Tahapan Penelitian : Recruit
Sponsor:
Mitra Pelaksana:
N/A
No Registry
INA-NYFZ1AL
Tanggal Input Registry : 25-04-2024

07-06-2023
Bioequivalence was concluded if the 90% confidence interval of the Test/Comparator geometric means ratio was in the range of 80.00 – 125.00% with 0.05 alpha, for AUC0-t and Cmax. This acceptance criterion is according to the Guideline on the Investigation of Bioequivalence, EMA, London, 2010; ASEAN Guideline for the Conduct of Bioequivalence Study, Lao PDR, 2015; and Indonesian guidelines, Tata Laksana Uji Bioekivalensi, Badan Pengawas Obat dan Makanan (BPOM), Jakarta, 2022.
 
Bioequivalence study of pramipexole dihydrochloride monohydrate 0.75 mg extended release tablet produced by PT Darya-Varia Laboratoria Tbk. in comparison with the comparator drug (Sifrol® ER 0.75 mg Extended Release Tablet produced by Boehringer Ingelheim Pharma GmbH & Co. KG, Germany, for Boehringer Ingelheim International GmbH, Germany, imported by PT Boehringer Ingelheim Indonesia, Indonesia)
Bioequivalence study of pramipexole dihydrochloride monohydrate 0.75 mg extended release tablet produced by PT Darya-Varia Laboratoria Tbk. in comparison with the comparator drug (Sifrol® ER 0.75 mg Extended Release Tablet produced by Boehringer Ingelheim Pharma GmbH & Co. KG, Germany, for Boehringer Ingelheim International GmbH, Germany, imported by PT Boehringer Ingelheim Indonesia, Indonesia)
Interventional
The present study was conducted to find out whether the bioavailability of pramipexole dihydrochloride monohydrate 0.75 mg extended release tablet produced by PT Darya-Varia Laboratoria Tbk. was equivalent to the comparator’s drug (Sifrol® ER 0.75 mg Extended Release Tablet produced by Boehringer Ingelheim Pharma GmbH & Co. KG, Germany, for Boehringer Ingelheim International GmbH, Germany, imported by PT Boehringer Ingelheim Indonesia, Indonesia) when administered under fasting condition in healthy subjects.
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Inclusion Criteria:

Participating subjects fulfilled the following criteria: 1. Able to participate, communicate well with the investigators and would provide written informed consent to participate in the study. 2. Healthy male subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation. 3. Aged 18 – 55 years inclusive. 4. Body mass index within 18 to 25 kg/m2. 5. Vital signs (after 10 minutes rest) were within the following ranges: Systolic blood pressure : 100 – 129 mmHg Diastolic blood pressure : 60 – 84 mmHg Pulse rate : 60 – 90 bpm 6. Willing to practice abstention or non-hormonal contraception during the study.

Exclusion Criteria:

1. History of allergy or hypersensitivity or contraindication to pramipexole or allied drug. 2. Smokers. 3. Any major illness in the past 90 days or clinically significant ongoing chronic medical illness. 4. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc. 5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV. 6. Positive result for COVID-19 antigen rapid test. 7. Clinically significant hematology abnormalities. 8. Clinically significant electrocardiogram (ECG) abnormalities. 9. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. 10. Past history of anaphylaxis or angioedema. 11. History of drug or alcohol abuse within 12 months prior to screening for this study. 12. Participation in any clinical trial within the past 90 days calculated from the last visit until this study’s first dosing day. 13. History of any bleeding or coagulative disorders. 14. Presence of difficulty in accessibility of veins in left or right arm. 15. A donation or significant blood loss within 90 days before this study’s first dosing day. 16. Intake of any prescription (especially pramipexole), non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day.
 
KET-183/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Mufid Idan Nugraha (PT Darya-Varia Laboratoria Tbk)