Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers - Full Text View

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 I

ChemIDplus related topics:

Mesalamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study

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

Further study details as provided by Procter and Gamble:

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
1: Experimental Asacol 6x400 mg Q24h at 7 am for 7 days	Drug: Asacol Asacol tablets, 6 tablets per day at 7 am for 7 days
2: Experimental 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
3: Experimental 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

Procter and Gamble

Investigators


Study Director:	William S Aronstein, MD, PhD	Procter and Gamble

More Information

Responsible Party:	Procter & Gamble ( William S Aronstein, MD, PhD )
Study ID Numbers:	2007011
First Received:	September 11, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00751699
Health Authority:	United States: Food and Drug Administration

Keywords provided by Procter and Gamble:

Pharmacokinetics

Study placed in the following topic categories:

Mesalamine

Healthy

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Sensory System Agents

Analgesics, Non-Narcotic

Therapeutic Uses

Physiological Effects of Drugs

Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents

Analgesics

Antirheumatic Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00751699