Overview

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

Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Holy Stone Healthcare Co., Ltd
Treatments:
Mesalamine