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Bioequivalence Bewteen DopaSnap® (Cabidopa/Levopdoap 25/100 mg Tablet) and Carbidopa/Levodopa 25/100 mg Tablet (Actavis)

NCT04236921 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2020-01-22

No results posted yet for this study

Summary

This will be a single center, bioequivalence and food-effect, open-label study designed to be conducted in three sequential parts:

Conditions

  • Other

Interventions

DRUG

DopaSnap®

immediate release CD/LD 25/100mg; Riverside Pharmaceuticals Corporation, USA

DRUG

RDL of CD-LD

(immediate release CD/LD 25/100mg; Merck Sharp \& Dohme Corp., USA),

Sponsors & Collaborators

  • Riverside Pharmacueticals Corporation

    lead INDUSTRY

Principal Investigators

  • Stephane Lamouche, PhD · Syneos Health

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2019-09-11
Completion
2019-12-01
FDA Drug
Yes

Countries

  • Canada

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 NCT04236921 on ClinicalTrials.gov