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