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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051685
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

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

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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

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



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-∞



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051685


Locations
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United States, North Dakota
Site 1
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Publications of Results:
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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT03051685    
Other Study ID Numbers: DFN-15-CD-003
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

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