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A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions

NCT00618202 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2018-01-23

No results posted yet for this study

Summary

The objective of this study was to assess the bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single 750 mg dose, administered under fasting conditions.

Conditions

Interventions

DRUG

Balsalazide

Sponsors & Collaborators

  • Roxane Laboratories

    lead INDUSTRY

Principal Investigators

  • So Ran Hong, M.D. · Novum Pharmaceutical Research Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2005-06-30
Completion
2005-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT00618202 on ClinicalTrials.gov