Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers
- Registration Number
- NCT00751699
- Lead Sponsor
- Warner Chilcott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Asacol Asacol 6x400 mg Q24h at 7 am for 7 days 2 Asacol Asacol 2x400 mg Q8h at 7 am, 3 pm, and 11 pm for 7 days 3 Lialda Lialda 2x1.2g Q24h at 7 am for 7 days
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇺🇸Miami, Florida, United States