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

Dr.Reddy's Laboratories

Status and phase

Completed

Phase 1

Conditions

Migraine

Treatments

Drug: DFN-15 (fasted)

Drug: Comparator Celebrex® (fed)

Drug: DFN-15 (fed)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03282838

DFN-15-CD-008

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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