Healthy
Conditions
Keywords
Pharmacokinetics
Brief summary
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.
Interventions
DRUGAsacol
Asacol tablets, 6 tablets per day at 7 am for 7 days
DRUGLialda
Lialda tablets 1.2 g, 2 tablets once a day at 7 am for 7 days
Sponsors
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed