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Bioequivalence Study of Pseudoephedrine HCl 120 mg ER Tablets Under Fed Conditions

NCT00779805 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2008-10-24

No results posted yet for this study

Summary

The objective of the study was to compare the single dose oral bioavailability of Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy with Sudafed 120 mg ER tablets of Pfizer Consumer Health Care in healthy, adult, human subjects under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Pseudoephedrine hydrochloride 120 mg ER tablets

Sponsors & Collaborators

  • Ranbaxy Laboratories Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2004-06-30
Completion
2004-10-31

Countries

  • India

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 NCT00779805 on ClinicalTrials.gov