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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282838
• Other study ID #: DFN-15-CD-008
• Status: Completed
• Phase: Phase 1
• First received: August 17, 2017
• Last updated: February 10, 2018
• Start date: June 9, 2017
• Est. completion date: January 12, 2018

Study information

• Verified date: February 2018
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 12, 2018
• Est. primary completion date: August 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine

Intervention

Drug:
• DFN-15 (fasted)
DFN-15 administered to fasted subjects
• DFN-15 (fed)
DFN-15 administered to fed subjects
• Comparator Celebrex® (fed)
Comparator (Celebrex®) administered to fed subjects

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFN-15 maximum plasma concentration (Cmax)		Up to 72 hours
Primary	DFN-15 area under the curve (AUC) 0-t		Up to 72 hours
Primary	DFN-15 area under the curve (AUC) 0-inf		Up to 72 hours