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Bioavailability of DFN-15 at 3 Different Doses vs. Comparator and to Determine Dose-proportionality of DFN-15 in Fasting Healthy Adults

NCT03051685 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-02-13

No results posted yet for this study

Summary

Crossover study to compare the BA of DFN-15 at 3 different doses versus the comparator to determine dose-proportionality of DFN-15 in healthy volunteers under fasting conditions

Conditions

  • Healthy

Interventions

DRUG

DFN-15 Dose 1

DRUG

DFN-15 Dose 2

DRUG

DFN-15 Dose 3

DRUG

Active Comparator

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-20
Primary Completion
2015-08-14
Completion
2015-11-10
FDA Drug
Yes

Countries

  • United States

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 NCT03051685 on ClinicalTrials.gov