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

NCT02196662 ↗

Phase 1 Completed 30 enrolled Holy Stone Healthcare Co., Ltd

RandomizedCrossoverOpen-label

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.

Timeline

Start: 2014-07
Primary completion: 2015-04
Completion: 2015-04

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mesalamine	Small molecule	400 mg	Oral

Indications

No indication recorded.