Healthy Clinical Trial
Official title:
Bioequivalence Study of 0.25 mg Pramipexole Tablets Produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals in Comparison With the Comparator Product (Sifrol® 0.25 mg Tablet, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany for Boehringer Ingelheim International, GmbH, Germany)
Verified date | January 2016 |
Source | Dexa Medica Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: National Agency of Drug and Food Control |
Study type | Interventional |
The present study was conducted to find out whether the bioavailability of 0.25 mg pramipexole tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals was equivalent to the reference drug (Sifrol® tablet 0.25 mg, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany).
Status | Completed |
Enrollment | 23 |
Est. completion date | June 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Healthy male or female subjects - Preferably non-smokers or smoke less than 10 cigarettes per day - Body mass index within 18 to 25 kg/m2 - Normal vital signs (after 10 minutes rest): systolic blood pressure 100 - 120 mmHg, diastolic blood pressure 60 - 80 mmHg, pulse rate 60 - 90 bpm Exclusion Criteria: - Personal / family history of allergy or hypersensitivity or contraindication to pramipexole or allied drugs - Pregnant or lactating women - Any major illness in the past 90 days or clinically significant ongoing chronic medical illness - Any clinically significant abnormal values of liver function test (ALT, alkaline phosphatase, total bilirubin >= 1.5 upper limit normal), renal function test (serum creatinine > 1.4 mg/dL), etc - Positive Hepatitis B surface antigen (HbsAg), anti-HCV, or anti-HIV - Clinically significant hematology abnormalities - Clinically significant ECG abnormalities - Any surgical or medical condition (present or history) which might significantly alter the pharmacokinetics of the study drug - History of anaphylaxis or angioedema - History of drug or alcohol abuse within 12 months prior to screening - Participation in any clinical trial within the past 90 days - History of any bleeding or coagulative disorders - History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm - A donation or loss of 300 mL (or more) of blood within 3 months before the study's first dosing day - Intake of any prescription, non-prescription drug, food supplement or herbal medicine within 14 days of the study's first dosing day |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Indonesia | PT Equilab International | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Dexa Medica Group |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUCt | Area under plasma concentration time curve from time zero to the last observed quantifiable concentration was determined from plasma concentrations of pramipexole from the test drug and reference drug. | 48 hours | No |
Primary | AUCinf | Area under plasma concentration time curve from time zero to infinity was determined from plasma concentrations of pramipexole from the test drug and reference drug. | 48 hours | No |
Primary | Cmax | The peak plasma concentration of the drug was determined from plasma concentrations of pramipexole from the test drug and reference drug. | 48 hours | No |
Secondary | Tmax | The time needed to achieve the peak plasma concentration was determined from plasma concentrations of pramipexole from the test drug and reference drug. | 48 hours | No |
Secondary | T1/2 | The elimination half life was determined from plasma concentrations of pramipexole from the test drug and reference drug. | 48 hours | No |
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