MedTrace Logo

Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg

NCT00649480 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-24

No results posted yet for this study

Summary

The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules to Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

BALSALAZIDE DISODIUM CAPSULES, 750 MG

3x750mg, single dose fed

DRUG

COLAZAL® Capsules 750 mg

3x750mg, single dose fed

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Alan K Copa, Pharm.D. · PRACS Institute, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • United States

Study Locations

More Related Trials

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 NCT00649480 on ClinicalTrials.gov