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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Warner Chilcott
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic endpoints of primary interest include AUC24 and the amount of 5-ASA excreted in the urine by subjects dosed with Asacol and Lialda.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
3
Lialda 2x1.2g Q24h at 7 am for 7 days
Intervention: Lialda (Drug)
1
Asacol 6x400 mg Q24h at 7 am for 7 days
Intervention: Asacol (Drug)
2
Asacol 2x400 mg Q8h at 7 am, 3 pm, and 11 pm for 7 days
Intervention: Asacol (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic endpoints of primary interest include AUC24 and the amount of 5-ASA excreted in the urine by subjects dosed with Asacol and Lialda.
Time Frame: Day 7
Secondary Outcomes
No secondary outcomes reported