Mesalamine 4 gm/60 mL Rectal Enema

Study Overview
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Brief Summary
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The objective of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the already marketed reference formulation Rowasa® in healthy, adult subjects.

Detailed Description
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Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Official Title
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A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 mL Rectal Enema Formulations

Conditions
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Healthy

Intervention / Treatment
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* Drug: Rowasa® 4 gm/60 mL Rectal Enema
* Drug: Mesalamine 4 gm/60 mL Rectal Enema


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, 18 years or older, with a body mass index (BMI) of 30 or less. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. Signed informed consent form, which meets all criteria of current FDA regulations. If female and of child bearing potential prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g. condom, IUD, hormonal contraceptives). Exclusion Criteria: If female pregnant, lactating, or likely to become pregnant during the study. History of allergy or sensitivity to mesalamine or other salicylic drugs (e.g. aspirin, sulfasalazine) or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study. Colitis, hemorrhoids, anal fissures, or other disease of the anus, rectum or colon. Significant history or current evidence of chronic infections disease, system disorder or organ disorder. History of psychiatric disorders occuring within the last two years that required hospitalization or medication. Presence of a medical condition requiring regular treatment with prescription drugs (other than contraceptives). Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing. Receipt of any drug as part of a research study within 30 days prior to dosing. Drug or alcohol addiction requiring treatment in the past 12 months. Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to dosing. Positive test for HIV, Hepatitis B surface antigen, or Hepatitis C antibody. Positive test results for drugs of abuse at screening. Positive serum pregnancy test at screening. Unable or unwilling to tolerate multiple venipunctures.

Ages Eligible for Study
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Minimum Age: 18 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesalamine<br>Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period | Drug: Mesalamine 4 gm/60 mL Rectal Enema<br>* 1 x 4 gm/60 mL, single-dose<br>|
| Active Comparator: Rowasa®<br>Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period | Drug: Rowasa® 4 gm/60 mL Rectal Enema<br>* 1 x 4 gm/60 mL, single-dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Concentration | Bioequivalence based on Cmax | Blood samples collected over 48 hour period | 
| AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | Bioequivalence based on AUC0-inf | Blood samples collected over 48 hour period | 
| AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) | Bioequivalence based on AUC0-t | Blood samples collected over 48 hour period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Concentration | Cmax results for N-Acetylmesalamine metabolite | Blood samples collected over 48 hour period | 
| AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | AUC0-inf results for N-Acetylmesalamine metabolite | Blood samples collected over 48 hour period | 
| AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) | AUC0-t results for N-Acetylmesalamine metabolite | Blood samples collected over 48 hour period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Healthy Subjects