Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium

Study Overview
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Brief Summary
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The purpose of this study is to assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product.

Detailed Description
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This study is an open-label, three-treatment, six sequence, three-period, single center crossover study to evaluate the pharmacokinetics of intravenous diclofenac sodium DIC075V (18.75 mg and 37.5 mg) versus oral diclofenac potassium (Cataflam® 50 mg) in healthy adult volunteers following single- and multiple-dose administration. Each treatment sequence received 1 dose every 6 hours (for a total of 4 doses per treatment sequence) with a 48-hour washout period between treatment sequences.

Official Title
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Open-Label, Randomized, Single Center Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses) Versus Oral Diclofenac Potassium in Healthy Adult Volunteers Following Single- and Multiple-Dose Administration

Conditions
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Healthy

Intervention / Treatment
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* Drug: Intravenous diclofenac sodium (DIC075V) 18.75 mg
* Drug: Intravenous diclofenac sodium (DIC075V) 37.5 mg
* Drug: Oral diclofenac potassium 50 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers between 18 and 55 years of age. Exclusion Criteria: Smoked or used tobacco or nicotine products in the past six months or expects to during the study. Known allergy or hypersensitivity to diclofenac, aspirin, or other NSAIDs. History of previous and/or present peptic ulceration, GI bleeding or any bleeding diathesis, positive for hepatitis B or hepatitis C or for HIV antibodies, or history of asthma.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Intravenous diclofenac sodium (DIC075V) 18.75 mg<br>* DIC075V 18.75 mg<br>|
| Experimental: 2<br> | Drug: Intravenous diclofenac sodium (DIC075V) 37.5 mg<br>* DIC075V 37.5 mg<br>|
| Active Comparator: 3<br> | Drug: Oral diclofenac potassium 50 mg<br>* Oral diclofenac potassium 50 mg<br>* Other names: Cataflam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product. |  | Several time points over 7 days |