Bioequivalence Study of Two Formulations of Pramipexole Tablets 0.25 mg

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660060
• Other study ID #: PR.193/EQL/2010
• Status: Completed
• Phase: N/A
• First received: January 14, 2016
• Last updated: January 17, 2016
• Start date: May 2015
• Est. completion date: June 2015

Study information

• 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

Clinical Trial 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).

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).

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Pramipexole Dexa Medica
Pramipexole 0.25 tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals as the test drug.
• Pramipexole Boehringer Ingelheim Pharma
Pramipexole 0.25 tablets produced by Boehringer Ingelheim Pharma GmbH & Co.KG for Boehringer Ingelheim International GmbH as the reference drug.

Locations

Country	Name	City	State
Indonesia	PT Equilab International	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dexa Medica Group

Country where clinical trial is conducted

Indonesia, 

Outcome

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