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

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