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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

Sponsor
Dr. Reddy's Laboratories Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT03051685
Collaborator
(none)
16
Enrollment
1
Location
4
Arms
3.7
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

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
  • 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
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Actual Study Start Date :
Jul 20, 2015
Actual Primary Completion Date :
Aug 14, 2015
Actual Study Completion Date :
Nov 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 [Up to 72 hours]

    DFN-15 maximum Plasma Concentration (Cmax)

  2. Pharmacokinetic (PK) parameters of DFN-15 [15 minutes]

    Area under the curve (AUC) 0-15 min

  3. Pharmacokinetic (PK) parameters of DFN-15 [30 minutes]

    Area under the curve (AUC) 0-30

  4. Pharmacokinetic (PK) parameters of DFN-15 [1 hour]

    Area under the curve (AUC) 0-1 hour

  5. Pharmacokinetic (PK) parameters of DFN-15 [2 hours]

    Area under the curve (AUC) 0-2 hours

  6. Pharmacokinetic (PK) parameters of DFN-15 [Up to 72 hours]

    Area under the curve (AUC) 0-T

  7. Pharmacokinetic (PK) parameters of DFN-15 [Up to 72 hours]

    Area under the curve (AUC) 0-RefTmax

  8. Pharmacokinetic (PK) parameters of DFN-15 [Up to 72 hours]

    Area under the curve (AUC) 0-∞

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Site City State Country Postal Code
1 Site 1 Fargo North Dakota United States 58104

Sponsors and Collaborators

  • Dr. Reddy's Laboratories Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT03051685
Other Study ID Numbers:
  • DFN-15-CD-003
First Posted:
Feb 14, 2017
Last Update Posted:
Feb 13, 2018
Last Verified:
Feb 1, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 13, 2018