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Safinamide Steady State Interaction With Rosuvastatin

NCT03216304 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-08-01

No results posted yet for this study

Summary

To evaluate if safinamide at the steady state, obtained after multiple 100 mg once a day administrations, has an effect on the pharmacokinetics of rosuvastatin, concomitantly administered as a single 20 mg dose, with respect to the pharmacokinetics of 20 mg rosuvastatin administered alone.

Conditions

  • Healthy

Interventions

DRUG

100 mg safinamide

Safinamide will be administered as follows: * Days 5-11: 100 mg safinamide (one Xadago® tablet), once a day * Day 12: a single dose of 100 mg safinamide (one Xadago® tablet), immediately followed by a single dose of 20 mg rosuvastatin calcium (one Crestor® tablet) * Days 13-15: 100 mg safinamide (one Xadago® tablet) once a day The medication will be orally administered in the morning, at 8:00±1h, under fasting conditions, with 240 mL (total volume) of still mineral water.

DRUG

20 mg rosuvastatin calcium period 1

Rosuvastatin will be administered as follows: \- Day 1: a single dose of 20 mg rosuvastatin calcium (one Crestor® tablet)

DRUG

20 mg rosuvastatin calcium period 2

\- Day 12: a single dose of 20 mg rosuvastatin calcium (one Crestor® tablet) immediately after the safinamide administration

Sponsors & Collaborators

  • Zambon SpA

    collaborator INDUSTRY

  • Cross Research S.A.

    lead INDUSTRY

Principal Investigators

  • Milko Radicioni, MD · CROSS Research SA, Phase I Unit, Via FA Giorgioli 12, 6864 Arzo Switzerland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2017-07-06
Completion
2017-07-06

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 NCT03216304 on ClinicalTrials.gov