NCT04236921

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

A Phase 1 Study to Evaluate the Bioequivalence Between DopaSnap® (Carbidopa/Levodopa 25/100 mg Tablet) and Carbidopa/Levodopa 25/100 mg Tablet and to Evaluate the Food-Effect of DopaSnap® in Normal Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Riverside Pharmacueticals Corporation · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This will be a single center, bioequivalence and food-effect, open-label study designed to be conducted in three sequential parts: * Part I: bioequivalence, food-effect, randomized, open-label, single dose, 3-period, 6-sequence, crossover design. * Part II: multiple-dose (every 4 hours), open-label, 1-period design. * Part III: multiple-dose (every 2 hours), open-label, 1-period design.

Conditions

• Other

Interventions

Type	Name	Description
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),

Timeline

• Start date: 2019-07-15
• Primary completion: 2019-09-11
• Completion: 2019-12-01
• First posted: 2020-01-22
• Last updated: 2020-01-22

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study