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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014