Healthy Clinical Trial
Official title:
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withdrawn as per criterion established under section 9.10 may be evaluated after completion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withdrawn due to adverse events or vomiting episodes will be presented but excluded from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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label
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