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

Study Overview
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Brief Summary
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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
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Healthy

Intervention / Treatment
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* Drug: DFN-15 Dose 1
* Drug: DFN-15 Dose 2
* Drug: DFN-15 Dose 3
* Drug: Active Comparator


Participation Criteria
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Eligibility Criteria
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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: 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 Exclusion Criteria: 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 Positive urine screening of alcohol and/or drugs of abuse Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B)) or anti Hepatitis C Virus (HCV (C)) tests Females who were pregnant according to a positive pregnancy test 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 Volunteers who donated plasma in the previous 14 days before day 1 of this study 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DFN-15 Dose 1<br> | Drug: DFN-15 Dose 1<br> <br> |
| Experimental: DFN-15 Dose 2<br> | Drug: DFN-15 Dose 2<br> <br> |
| Experimental: DFN-15 Dose 3<br> | Drug: DFN-15 Dose 3<br> <br> |
| Active Comparator: Active Comparator<br> | Drug: Active Comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |