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

• ClinicalTrials.gov Identifier: NCT03051685
• Recruitment Status: Completed
• First Posted: February 14, 2017
• Last Update Posted: February 13, 2018
• Sponsor: Dr. Reddy's Laboratories Limited
• Information provided by (Responsible Party): Dr. Reddy's Laboratories Limited

Study Description

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: DFN-15 Dose 1; Drug: DFN-15 Dose 2; Drug: DFN-15 Dose 3; Drug: Active Comparator	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Actual Study Start Date: July 20, 2015
• Actual Primary Completion Date: August 14, 2015
• Actual Study Completion Date: November 10, 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: DFN-15 Dose 1	Drug: DFN-15 Dose 1
Experimental: DFN-15 Dose 2	Drug: DFN-15 Dose 2
Experimental: DFN-15 Dose 3	Drug: DFN-15 Dose 3
Active Comparator: Active Comparator	Drug: Active Comparator

Outcome Measures

Primary Outcome Measures :

1. Pharmacokinetic (PK) parameters of DFN-15 [ Time Frame: Up to 72 hours ]
   DFN-15 maximum Plasma Concentration (Cmax)
2. Pharmacokinetic (PK) parameters of DFN-15 [ Time Frame: 15 minutes ]
   Area under the curve (AUC) 0-15 min
3. Pharmacokinetic (PK) parameters of DFN-15 [ Time Frame: 30 minutes ]
   Area under the curve (AUC) 0-30
4. Pharmacokinetic (PK) parameters of DFN-15 [ Time Frame: 1 hour ]
   Area under the curve (AUC) 0-1 hour
5. Pharmacokinetic (PK) parameters of DFN-15 [ Time Frame: 2 hours ]
   Area under the curve (AUC) 0-2 hours
6. Pharmacokinetic (PK) parameters of DFN-15 [ Time Frame: Up to 72 hours ]
   Area under the curve (AUC) 0-T
7. Pharmacokinetic (PK) parameters of DFN-15 [ Time Frame: Up to 72 hours ]
   Area under the curve (AUC) 0-RefTmax
8. Pharmacokinetic (PK) parameters of DFN-15 [ Time Frame: Up to 72 hours ]
   Area under the curve (AUC) 0-∞

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

Subjects were male or female, at least 18 years of age but not older than 45 years of age. The main inclusion criteria were:

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

Exclusion Criteria:

1. Females who were pregnant or were lactating
2. 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
3. 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
4. History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
5. Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
6. 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
7. 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
8. History or current hypertension, bleeding disorders, ischaemic heart disease, stroke and/or cerebrovascular disease or renal disease
9. History of asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid (ASA) or other NSAIDs
10. Presence or history of gastric, duodenal or peptic ulcer or gastrointestinal bleeding
11. Use of ASA or NSAIDs, or any product containing ASA or NSAIDs, in the previous 7 days before day 1 of this study
12. Known presence of rare hereditary problems of galactose and /or lactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
13. 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
14. Any clinically significant illness in the previous 28 days before day 1 of this study
15. Any history of tuberculosis and/or prophylaxis for tuberculosis
16. Positive urine screening of alcohol and/or drugs of abuse
17. Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B)) or anti Hepatitis C Virus (HCV (C)) tests
18. Females who were pregnant according to a positive pregnancy test
19. Volunteers who took an investigational product (in another clinical trial) in the previous 28 days before day 1 of this study or who had already participated in this clinical study
20. Volunteers who donated plasma in the previous 14 days before day 1 of this study
21. Donation of 500 mL or more of blood (American Red Cross, clinical studies, etc.) in the previous 56 days before day 1 of this study

Contacts and Locations

Locations

United States, North Dakota

Site 1

Fargo, North Dakota, United States, 58104

Sponsors and Collaborators

Dr. Reddy's Laboratories Limited

More Information

Publications of Results:

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.

• Responsible Party: Dr. Reddy's Laboratories Limited
• ClinicalTrials.gov Identifier: NCT03051685
• Other Study ID Numbers: DFN-15-CD-003
• First Posted: February 14, 2017
• Last Update Posted: February 13, 2018
• Last Verified: February 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No