Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Asacol 6x400 mg Q24h at 7 am for 7 days |
Drug: Asacol
Asacol tablets, 6 tablets per day at 7 am for 7 days
|
| Experimental: 2 Asacol 2x400 mg Q8h at 7 am, 3 pm, and 11 pm for 7 days |
Drug: Asacol
Asacol tablets, 400 mg, 2 tablets at 7 am, 3 pm, and 11 pm for 7 days
|
| Experimental: 3 Lialda 2x1.2g Q24h at 7 am for 7 days |
Drug: Lialda
Lialda tablets 1.2 g, 2 tablets once a day at 7 am for 7 days
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
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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;
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Able to swallow the assigned study medication tablet whole; and,
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Able to fulfill the requirements of the protocol and provide written informed consent.
Exclusion Criteria:
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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);
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Miami | Florida | United States |
Sponsors and Collaborators
- Warner Chilcott
Investigators
- Study Director: William S Aronstein, MD, PhD, Procter and Gamble
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2007011