NCT02196662

Pharmacokinetics of IBD98-M 400mg-57.5/Day in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Holy Stone Healthcare Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 Data from subjects who experienced emesis during the sampling interval and who were not withdrawn as per criterion established under section 9.10 may be evaluated after completion of the pharmacokinetic analysis.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parameters) from subjects excluded due to a pre dose concentration greater than 5% of their Cmax or from subjects withdrawn due to adverse events or vomiting episodes will be presented but excluded from descriptive statistics.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	IBD98-M:	single adiministration
DRUG	IBD98-M without HA	single adiministration
DRUG	Delzicol	single adiministration

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-07-22
• Last updated: 2015-04-22

Locations

1 site across 1 country: Canada