NCT02660060

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

Same day

First QC Date

January 14, 2016

Last Update Submit

January 17, 2016

Conditions

Healthy

Keywords

PramipexoleBioequivalencePharmacokinetics

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Cmax

    The peak plasma concentration of the drug was determined from plasma concentrations of pramipexole from the test drug and reference drug.

    48 hours

Secondary Outcomes (2)

  • Tmax

    48 hours

  • T1/2

    48 hours

Study Arms (2)

Pramipexole Dexa Medica

EXPERIMENTAL

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.

Drug: Pramipexole Dexa Medica

Pramipexole Boehringer Ingelheim Pharma

ACTIVE COMPARATOR

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.

Drug: Pramipexole Boehringer Ingelheim Pharma

Interventions

Pramipexole Dexa MedicaDRUG

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

Pramipexole Dexa Medica
Pramipexole Boehringer Ingelheim PharmaDRUG

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

Also known as: Sifrol®
Pramipexole Boehringer Ingelheim Pharma

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PT Equilab International

Jakarta, Jakarta Special Capital Region, 12430, Indonesia

Location

MeSH Terms

Interventions

Pramipexole

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ratih SI Putri, MD

    PT Equilab International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 21, 2016

Study Start

May 1, 2015

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

January 21, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)