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Bioequivalence Study of Two Formulations of Pramipexole Tablets 0.25 mg

NCT02660060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2016-01-21

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

DRUG

Pramipexole Dexa Medica

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

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.

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Ratih SI Putri, MD · PT Equilab International

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02660060 on ClinicalTrials.gov