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Evaluate Bioequivalence of Palonosetron (0.25mg/5mL)

NCT04585412 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-08-04

No results posted yet for this study

Summary

A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of palonosetron after intravenous administration of palonosetron in healthy volunteers under fasting conditions.

Conditions

  • Chemotherapy-induced Nausea and Vomiting, Prophylaxis

Interventions

DRUG

Palonosetron

Pharmacokinetic study under fasting conditions

Sponsors & Collaborators

  • Yung Shin Pharm. Ind. Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-08-17
Primary Completion
2020-10-24
Completion
2020-12-31

Countries

  • Taiwan

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 NCT04585412 on ClinicalTrials.gov