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

NCT03282838 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-02-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-09
Primary Completion
2017-08-22
Completion
2018-01-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03282838 on ClinicalTrials.gov