NCT03282838

Study on the Pharmacokinetics (PK) of DFN-15 vs Comparator and Food-effect on DFN-15 PK in Healthy Adult Subjects

Open-Label, Three Way, Randomized, Single Dose Crossover Study Comparing Bioavailability of DFN-15 Oral Solution Under Fasting Conditions vs Comparator Under Fed Conditions and to Determine Food Effect of DFN-15 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

An Open-Label, Three-Way Randomized, Single Dose Crossover Study Comparing Bioavailability of DFN-15 under fasting conditions versus Comparator under fed conditions and to determine food-effect of DFN-15 in Healthy Adult Subjects

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	DFN-15 (fasted)	DFN-15 administered to fasted subjects
DRUG	DFN-15 (fed)	DFN-15 administered to fed subjects
DRUG	Comparator Celebrex® (fed)	Comparator (Celebrex®) administered to fed subjects

Timeline

• Start date: 2017-06-09
• Primary completion: 2017-08-22
• Completion: 2018-01-12
• First posted: 2017-09-14
• Last updated: 2018-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study