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

NCT03051685 | Completed Phase 1 FDA Drug

• 1 other identifier: DFN-15-CD-003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (8)

• Pharmacokinetic (PK) parameters of DFN-15

  DFN-15 maximum Plasma Concentration (Cmax)

  Up to 72 hours

• Pharmacokinetic (PK) parameters of DFN-15

  Area under the curve (AUC) 0-15 min

  15 minutes

• Pharmacokinetic (PK) parameters of DFN-15

  Area under the curve (AUC) 0-30

  30 minutes

• Pharmacokinetic (PK) parameters of DFN-15

  Area under the curve (AUC) 0-1 hour

  1 hour

• Pharmacokinetic (PK) parameters of DFN-15

  Area under the curve (AUC) 0-2 hours

  2 hours

• Pharmacokinetic (PK) parameters of DFN-15

  Area under the curve (AUC) 0-T

  Up to 72 hours

• Pharmacokinetic (PK) parameters of DFN-15

  Area under the curve (AUC) 0-RefTmax

  Up to 72 hours

• Pharmacokinetic (PK) parameters of DFN-15

  Area under the curve (AUC) 0-∞

  Up to 72 hours

Study Arms (4)

DFN-15 Dose 1

EXPERIMENTAL

Drug: DFN-15 Dose 1

DFN-15 Dose 2

EXPERIMENTAL

Drug: DFN-15 Dose 2

DFN-15 Dose 3

EXPERIMENTAL

Drug: DFN-15 Dose 3

Active Comparator

ACTIVE COMPARATOR

Drug: Active Comparator

Interventions

DFN-15 Dose 1 DRUG

DFN-15 Dose 1

DFN-15 Dose 2 DRUG

DFN-15 Dose 2

DFN-15 Dose 3 DRUG

DFN-15 Dose 3

Active Comparator DRUG

Active Comparator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• non- or ex-smokers
• body mass index (BMI) ≥18.50 kg/m2 and \<30.00 kg/m2
• no clinically significant abnormality found in the 12-lead ECG performed at study entry
• negative pregnancy test for female subjects
• healthy according to medical history, complete physical examination (including vital signs) and laboratory tests (general biochemistry, hematology, urinalysis, and coagulation)
• Fecal occult blood determination negative at screening

You may not qualify if:

• Females who were pregnant or were lactating
• Patients who had a history of allergic reactions to non-steroidal anti-inflammatory drugs (NSAIDs), including patients in whom aspirin or other NSAIDs induce the syndrome of asthma, rhinitis, nasal polyps or Samter's triad
• Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
• History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
• Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
• Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases, neurological impairment or cognitive dysfunction that, in the opinion of the investigator, would compromise validity of informed consent, study participation and compliance or data collection
• Presence of out-of-range cardiac intervals and/ or morphological changes suggestive of arrhythmias or ischaemic heart disease on the screening electrocardiogram (ECG) or other clinically significant ECG abnormalities
• History or current hypertension, bleeding disorders, ischaemic heart disease, stroke and/or cerebrovascular disease or renal disease
• History of asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid (ASA) or other NSAIDs
• Presence or history of gastric, duodenal or peptic ulcer or gastrointestinal bleeding
• Use of ASA or NSAIDs, or any product containing ASA or NSAIDs, in the previous 7 days before day 1 of this study
• Known presence of rare hereditary problems of galactose and /or lactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Maintenance therapy with any drug or significant history of drug dependency (including marijuana and medical marijuana) or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic) within 1 year
• Any clinically significant illness in the previous 28 days before day 1 of this study
• Any history of tuberculosis and/or prophylaxis for tuberculosis

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Site 1

Fargo, North Dakota, 58104, United States

Location

Related Publications (1)

• Pal A, Shenoy S, Gautam A, Munjal S, Niu J, Gopalakrishnan M, Gobburru J. Pharmacokinetics of DFN-15, a Novel Oral Solution of Celecoxib, Versus Celecoxib 400-mg Capsules: A Randomized Crossover Study in Fasting Healthy Volunteers. Clin Drug Investig. 2017 Oct;37(10):937-946. doi: 10.1007/s40261-017-0548-6.

  PMID: 28748412 RESULT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 14, 2017
• Study Start: July 20, 2015
• Primary Completion: August 14, 2015
• Study Completion: November 10, 2015
• Last Updated: February 13, 2018

Record last verified: 2018-02

Locations

US (1)