Pharmacokinetics of IBD98-M 400mg-57.5/Day in Healthy Volunteers
Pharmacokinetics of IBD98-M 400mg-57.5/Day in Healthy Volunteers
The primary objective of this study is to compare the rate and extent of absorption of
 mesalamine-sodium hyaluronate 200 mg-28.75 mg delayed-release capsule (IBD98-M, Test) versus
 Delzicol 400 mg delayed-release capsule (mesalamine Reference), administered as a single oral
 dose of 2 x 200 mg-28.75 mg delayed-release capsule (total dose of 400 mg-57.50 mg) or 1 x
 400 mg delayed-release capsule under fasting conditions.
Safety population The safety population is defined as all subjects who received at least one
 dose of the study medication.

 Pharmacokinetic Population The pharmacokinetic population will include all subjects
 completing at least 2 periods and for whom the pharmacokinetic profile can be adequately
 characterised.

 Any subject with pre-dose concentrations for mesalamine will be excluded from the
 pharmacokinetic population for this analyte if the pre-dose concentration is greater than 5%
 of the Cmax value of that period for this subject.

 Data from subjects who experienced emesis during the sampling interval and who were not
 withdrawn as per criterion established under section 9.10 may be evaluated after completion
 of the pharmacokinetic analysis. Any subject who experienced emesis within 2 times median
 Tmax of the current study (based on the Reference product) will be excluded from the
 statistical analysis. Data (concentrations and pharmacokinetic parameters) from subjects
 excluded due to a pre dose concentration greater than 5% of their Cmax or from subjects
 withdrawn due to adverse events or vomiting episodes will be presented but excluded from
 descriptive statistics.
Inclusion Criteria:

 1. Male or female, smoker (no more than 25 cigarettes daily) or non-smoker, 18 years of
 age and older, with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males
 and ≥ 45.0 kg for females.

 2. Healthy as defined by:

 -  the absence of clinically significant illness and surgery within 4 weeks prior to
 dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated
 for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the
 Qualified Investigator.

 -  the absence of clinically significant history of neurological, endocrinal,
 cardiovascular, pulmonary, hematological, immunologic, psychiatric,
 gastrointestinal, renal, hepatic, and metabolic disease.

 -  the absence of history or known pyloric stenosis.

 -  the absence of known gastric or duodenal ulcer.

 -  the absence of urinary tract obstruction.

 3. Females of childbearing potential who are sexually active with a male partner must be
 willing to use one of the following acceptable contraceptive method throughout the
 study and for 30 days after the last study drug administration:

 -  intra-uterine contraceptive device placed at least 4 weeks prior to study drug
 administration

 -  condom with intravaginally applied spermicide starting at least 14 days prior to
 study drug administration

 -  hormonal contraceptives starting at least 4 weeks prior to study drug
 administration and must agree to use the same hormonal contraceptive throughout
 the study

 -  sterile male partner (vasectomized since at least 6 months).

 4. Capable of consent.

 Exclusion Criteria:

 1. Any clinically significant abnormality or abnormal laboratory test results found
 during medical screening or positive test for hepatitis B, hepatitis C, or HIV found
 during medical screening.

 2. Positive urine drug screen at screening.

 3. History of allergic reactions to mesalamine, salicylates, aminosalicylates, hyaluronic
 acid, or other related drugs.

 4. Positive pregnancy test at screening.

 5. Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the
 subject from participating in the study.

 6. Clinically significant electrocardiogram (ECG) abnormalities or vital sign
 abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood
 pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at
 screening.

 7. History of significant alcohol abuse within one year prior to screening or regular use
 of alcohol within six months prior to the screening visit (more than fourteen units of
 alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).

 8. History of significant drug abuse within one year prior to screening or use of soft
 drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs
 (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening.

 9. Participation in a clinical trial involving the administration of an investigational
 or marketed drug within 30 days (90 days for biologics) prior to the first dosing or
 concomitant participation in an investigational study involving no drug
 administration.

 10. Use of medication other than topical products without significant systemic absorption
 and hormonal contraceptives:

 -  prescription medication within 14 days prior to the first dosing;

 -  over-the-counter products including natural health products (e.g. food
 supplements and herbal supplements) within 7 days prior to the first dosing, with
 the exception of the occasional use of acetaminophen (up to 2 g daily);

 -  a depot injection or an implant of any drug (other than hormonal contraceptives)
 within 3 months prior to the first dosing.

 11. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding
 volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than
 499 mL within 56 days prior to the first dosing.

 12. Hemoglobin <128 g/L (males) and <115 g/L (females) and hematocrit <0.37 L/L (males)
 and <0.32 L/L (females) at screening.

 13. Breast-feeding subject.