Clinical trial NCT02660060: Bioequivalence Study of Two Formulations of Pramipexole Tablets 0.25 mg
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Pramipexole
Bioequivalence
Pharmacokinetics
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2016-01-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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).

Detailed description: This was a randomized, open label, two-period, two-sequence, crossover study under fasting condition. The participating subjects were required to have an overnight fast and in the next morning were given orally one tablet of the test drug (Pramipexole 0.25 mg produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals) or one tablet of the reference drug (Sifrol® 0.25 mg, Boehringer Ingelheim Pharma GmbH \& Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany).

Blood samples were drawn immediately before taking the drug (control), at 20, 40 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours after drug administration. Seven days after the first drug administration (washout period), the procedure was repeated using the alternate drug. The plasma concentrations of pramipexole were determined by validated ultra performance liquid chromatography with mass spectrometry detector (UPLC-MS/MS).

Eligibility criteria: 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

Primary outcomes:
measure: AUCt
timeFrame: 48 hours
measure: AUCinf
timeFrame: 48 hours
measure: Cmax
timeFrame: 48 hours
Secondary outcomes:
measure: Tmax
timeFrame: 48 hours
measure: T1/2
timeFrame: 48 hours
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: PT Equilab International
Study officials:
affiliation: PT Equilab International
name: Ratih SI Putri, MD
role: PRINCIPAL_INVESTIGATOR
References: