Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers

Warner Chilcott

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Asacol

Drug: Lialda

Study type

Interventional

Funder types

Industry

Identifiers

NCT00751699

2007011

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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