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

NCT ID: NCT03282838

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-09
• Study Completion Date: 2018-01-12

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

DFN-15 (fasted)

Group Type: EXPERIMENTAL

DFN-15 (fasted)

Intervention Type: DRUG

DFN-15 administered to fasted subjects

DFN-15 (fed)

Group Type: EXPERIMENTAL

DFN-15 (fed)

Intervention Type: DRUG

DFN-15 administered to fed subjects

Comparator (fed)

Group Type: EXPERIMENTAL

Comparator Celebrex® (fed)

Intervention Type: DRUG

Comparator (Celebrex®) administered to fed subjects

Interventions

DFN-15 (fasted)

DFN-15 administered to fasted subjects

Intervention Type: DRUG

DFN-15 (fed)

DFN-15 administered to fed subjects

Intervention Type: DRUG

Comparator Celebrex® (fed)

Comparator (Celebrex®) administered to fed subjects

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Celerion

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

DFN-15-CD-008

Identifier Type: -

Identifier Source: org_study_id