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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00751699
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : April 17, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Asacol Drug: Lialda Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : March 2007
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00751699

United States, Florida
Research Site
Miami, Florida, United States
Sponsors and Collaborators
Warner Chilcott
Study Director: William S Aronstein, MD, PhD Procter and Gamble

Responsible Party: Warner Chilcott Identifier: NCT00751699     History of Changes
Other Study ID Numbers: 2007011
First Posted: September 12, 2008    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013

Keywords provided by Warner Chilcott:

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents