Bioequivalence Study of Two Formulations of Pramipexole Tablets 0.25 mg

NCT ID: NCT02660060

Last Updated: 2016-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-06-30

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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Pramipexole Dexa Medica

Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate. An oral single dose of the tablet was administered at the first day of each treatment period.

Group Type: EXPERIMENTAL

Pramipexole Dexa Medica

Intervention Type: DRUG

Pramipexole 0.25 tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals as the test drug.

Pramipexole Boehringer Ingelheim Pharma

Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate. An oral single dose of the tablet was administered at the first day of each treatment period.

Group Type: ACTIVE_COMPARATOR

Pramipexole Boehringer Ingelheim Pharma

Intervention Type: DRUG

Pramipexole 0.25 tablets produced by Boehringer Ingelheim Pharma GmbH \& Co.KG for Boehringer Ingelheim International GmbH as the reference drug.

Interventions

Pramipexole Dexa Medica

Pramipexole 0.25 tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals as the test drug.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Sifrol®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dexa Medica Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ratih SI Putri, MD

Role: PRINCIPAL_INVESTIGATOR

PT Equilab International

Locations

PT Equilab International

Jakarta, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Other Identifiers

PR.193/EQL/2010

Identifier Type: -

Identifier Source: org_study_id