Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers

Study Overview
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Brief Summary
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This study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3 regimens of oral mesalamine 2.4 g/day (Lialda 2.4 g/day 2 x 1.2 g every 24 hours, Asacol® 6 x 400 mg every 24 hours, or Asacol 2 x 400 mg every 8 hours). Primary endpoints were 5-ASA area under the plasma concentration versus time curve from zero to 24 hours (AUC24) and total 5-ASA percent of dose excreted (A'e [%]) over the 24-hour period on Day 7.

Official Title
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A Randomized, Open-label, Multiple Dose, Parallel Group Study to Evaluate 5 ASA and N Ac 5 ASA Pharmacokinetics Following Administration of Oral Doses of Asacol 2.4 g/Day and Lialda 2.4 g/Day for 7 Days in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Asacol
* Drug: Asacol
* Drug: Lialda


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females between 18 and 45 years of age, inclusive, at screening and in good general health based on medical history, physical examination, and laboratory evaluation; If female, must be (as documented by patient reported medical history): postmenopausal (at least 1 year without spontaneous menses), or surgically sterile (tubal ligation or hysterectomy), or using acceptable contraception [e.g., sexual partner with non-reversed vasectomy (with azoospermia in 2 tests), 2 barrier methods (e.g., condom, diaphragm, or spermicide), or intra-uterine device]; Body mass index (BMI) between 18 and 32 kg/m2, inclusive; Able to swallow the assigned study medication tablet whole; and, Able to fulfill the requirements of the protocol and provide written informed consent. Exclusion Criteria: History or presence of any condition or gastrointestinal (GI) surgery causing malabsorption or an effect on GI motility; Any uncontrolled acute disease or major surgical operation requiring hospitalization within 1 month of screening; History of diabetes, syncope, cardiovascular, hepatic, or renal disease; Uncontrolled chronic diseases such as hypertension, systemic lupus erythematosus, or rheumatoid arthritis; History of cancer within the last 5 years (except for basal cell carcinoma with a documented 6-month remission); Any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides within 30 days of treatment; Any prescription drug or herbal remedy within 14 days prior to scheduled dosing

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Asacol 6x400 mg Q24h at 7 am for 7 days | Drug: Asacol<br>* Asacol tablets, 6 tablets per day at 7 am for 7 days<br>|
| Experimental: 2<br>Asacol 2x400 mg Q8h at 7 am, 3 pm, and 11 pm for 7 days | Drug: Asacol<br>* Asacol tablets, 400 mg, 2 tablets at 7 am, 3 pm, and 11 pm for 7 days<br>|
| Experimental: 3<br>Lialda 2x1.2g Q24h at 7 am for 7 days | Drug: Lialda<br>* Lialda tablets 1.2 g, 2 tablets once a day at 7 am for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic endpoints of primary interest include AUC24 and the amount of 5-ASA excreted in the urine by subjects dosed with Asacol and Lialda. |  | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics