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

NCT02196662 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-04-22

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

IBD98-M:

single adiministration

DRUG

IBD98-M without HA

single adiministration

DRUG

Delzicol

single adiministration

Sponsors & Collaborators

  • Holy Stone Healthcare Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Denis Audet, M.D. · inVentiv

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02196662 on ClinicalTrials.gov