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Granisetron 1 mg Tablets, Non-fasting

NCT00834522 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-08-19

Study results available
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Summary

The objective of this study is to evaluate the comparative bioavailability between granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets (Roche, USA), after a single-dose in health subjects under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Granisetron hydrochloride 1 mg tablets

2 x 1 mg, single dose non-fasting

DRUG

Kytril® 1 mg tablets

2 x 1 mg, single dose non-fasting

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Xueyu (Eric) Chen, M.D., Ph. D. · Pharma Medica

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2005-07-31
Completion
2005-07-31

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 NCT00834522 on ClinicalTrials.gov