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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00751699
First Posted: September 12, 2008
Last Update Posted: April 17, 2013
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.
Information provided by (Responsible Party):
Warner Chilcott
  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
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

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00751699     History of Changes
Other Study ID Numbers: 2007011
First Submitted: September 11, 2008
First Posted: September 12, 2008
Last Update Posted: April 17, 2013
Last Verified: April 2013

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
Anti-Inflammatory Agents
Antirheumatic Agents