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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00751699
First received: September 11, 2008
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Healthy
Drug: Asacol
Drug: Lialda
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

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. [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: March 2007
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751699

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

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00751699     History of Changes
Other Study ID Numbers: 2007011
Study First Received: September 11, 2008
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Warner Chilcott:
Pharmacokinetics

Additional relevant MeSH terms:
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014