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Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers

NCT02495831 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-04-15

Study results available
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Summary

To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with respect to 50 mg diclofenac sodium administered alone.

Conditions

  • Healthy

Interventions

DRUG

Diclofenac sodium

Diclofenac sodium 50 mg single dose

DRUG

Diclofenac sodium and safinamide

Diclofenac 50 mg single dose and safinamide 200 mg single dose

Sponsors & Collaborators

  • Cross Research S.A.

    collaborator INDUSTRY

  • Zambon SpA

    lead INDUSTRY

Principal Investigators

  • Milko Radicioni, MD · Cross Research SA

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Switzerland

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 NCT02495831 on ClinicalTrials.gov