CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Diclofenac sodium +1 moredrug
Likely dose
Diclofenac sodium 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02495831
NCT02495831Phase 1Completed
CompareCT.gov

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

Zambon SpA·interventional·Posted Jul 13, 2015·Updated Apr 15, 2016

In Brief

A Phase 1 clinical trial evaluating Diclofenac sodium and Diclofenac sodium and safinamide for Healthy. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSwitzerland
CollaboratorsCross Research S.A.

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 13, 2015
Enrollment StartMay 1, 2015
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 11.0 years ago

Interventions

Diclofenac sodiumdrug

Diclofenac sodium 50 mg single dose

Diclofenac sodium and safinamidedrug

Diclofenac 50 mg single dose and safinamide 200 mg single dose