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Bioequivalence Study of Gefitinib Tablets Under Fasting Conditions

NCT03050164 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-02-10

No results posted yet for this study

Summary

The study design is an Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence Study. During each session, the subjects will be administered a single dose of 250mg Gefitinib Tablet (one Gefitinib Tablet 250mg of Hunan Kelun or one Iressa® Tablet 250mg of AstraZeneca) under fasting conditions.

Conditions

  • Bioequivalence Study

Interventions

DRUG

Gefitinib Tablet 250mg of Hunan Kelun

Single dose of Gefitinib Tablet 250mg of Hunan Kelun was administered after a 10-hour overnight fast.

DRUG

Iressa® Tablet 250mg of AZN

Single dose of Iressa® Tablet 250mg of AZN was administered after a 10-hour overnight fast.

Sponsors & Collaborators

  • Hunan Kelun Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-08
Primary Completion
2016-11-04
Completion
2016-11-04

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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 NCT03050164 on ClinicalTrials.gov