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

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

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: DFN-15 (fasted); Drug: DFN-15 (fed); Drug: Comparator Celebrex® (fed)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy, adult, male or female 19-55 years of age, inclusive, at screening.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
• Females of childbearing potential: must either be sexually inactive (abstinent) for 30 days prior to the first dose and throughout the study or be using birth control method; Female subjects of non-childbearing potential and must have undergone sterilization procedures or be postmenopausal for at least 1 year prior
• Male subject must agree to use contraception or abstain during the study until 90 days beyond the last dose of study drug.
• Understands the study procedures in the informed consent form (ICF), and willing and able to comply with the protocol.

Exclusion Criteria:

• History or presence of hypersensitivity or idiosyncratic reaction to celecoxib, sulfonamides, aspirin or other NSAIDs or related compounds
• History or presence of clinically significant medical or psychiatric condition or disease
• History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study
• liver enzyme tests greater than the upper limit of normal at screening
• Estimated creatinine clearance <90 mL/minute at screening
• History or presence of alcoholism
• History or presence of bilateral pedal edema or generalized edema or fluid retention
• Female subjects who are pregnant or lactating or actively trying to conceive
• Positive urine drug or alcohol results at screening or check-in
• Positive cotinine at screening
• Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
• Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening
• Seated heart rate is lower than 45 bpm or higher than 100 bpm at screening
• Has been on a diet incompatible with the on-study diet
• Unable to refrain from or anticipates the use of prohibited medications
• Donation of blood or significant blood loss within 56 days prior to the first dose of study drug; plasma donation within 7 days prior to the first dose of study drug
• Participation in another clinical trial within 28 days prior to the first dose of study drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DFN-15 (fasted)	Drug: DFN-15 (fasted); DFN-15 administered to fasted subjects
Experimental: DFN-15 (fed)	Drug: DFN-15 (fed); DFN-15 administered to fed subjects
Experimental: Comparator (fed)	Drug: Comparator Celebrex® (fed); Comparator (Celebrex®) administered to fed subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
DFN-15 maximum plasma concentration (Cmax)	Up to 72 hours
DFN-15 area under the curve (AUC) 0-t	Up to 72 hours
DFN-15 area under the curve (AUC) 0-inf	Up to 72 hours

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2017
• Primary Completion (Actual): August 22, 2017
• Study Completion (Actual): January 12, 2018

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 10, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: DFN-15-CD-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No