Status:
COMPLETED
Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers
Lead Sponsor:
Warner Chilcott
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 ho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00751699
Start Date
March 1 2007
End Date
April 1 2007
Last Update
April 17 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Miami, Florida, United States