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

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ClinicalTrials.gov Identifier: NCT00751699
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : April 17, 2013
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Tracking Information
First Submitted Date  ICMJE September 11, 2008
First Posted Date  ICMJE September 12, 2008
Last Update Posted Date April 17, 2013
Study Start Date  ICMJE March 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Asacol
    Asacol tablets, 6 tablets per day at 7 am for 7 days
  • Drug: Asacol
    Asacol tablets, 400 mg, 2 tablets at 7 am, 3 pm, and 11 pm for 7 days
  • Drug: Lialda
    Lialda tablets 1.2 g, 2 tablets once a day at 7 am for 7 days
Study Arms  ICMJE
  • Experimental: 1
    Asacol 6x400 mg Q24h at 7 am for 7 days
    Intervention: Drug: Asacol
  • Experimental: 2
    Asacol 2x400 mg Q8h at 7 am, 3 pm, and 11 pm for 7 days
    Intervention: Drug: Asacol
  • Experimental: 3
    Lialda 2x1.2g Q24h at 7 am for 7 days
    Intervention: Drug: Lialda
Publications * Vande Casteele N, Jakate A, McNamee B, Sandborn WJ. Similar pharmacokinetics of three dosing regimens comprising two oral delayed-release mesalamine formulations in healthy adult volunteers: Randomised, open-label, parallel-group study. Br J Clin Pharmacol. 2020 Jul 15. doi: 10.1111/bcp.14479. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2008)
37
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00751699
Other Study ID Numbers  ICMJE 2007011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Warner Chilcott
Study Sponsor  ICMJE Warner Chilcott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: William S Aronstein, MD, PhD Procter and Gamble
PRS Account Warner Chilcott
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP