Open-label Study Using 50 Mg Liquid Etanercept Subcutaneous Injection in the Thigh to Compare an Auto-injector Device and a Manual Injection in Healthy Subjects

Healthy Men and Women Clinical Trial

Official title:
An Open-label, Randomized, 2-period Crossover Bioequivalence Study Comparing a 50-mg Dose of Liquid Etanercept Administered to Healthy Subjects by Subcutaneous Injection in the Thigh Using an Auto-injector Device and Manual Injection

Status Completed

Clinical Trial Summary

A single-center, open-label, randomized study with a screening period of up to 21 days. Following that, eligible men and women will receive 50 mg of etanercept subcutaneously in the thigh to compare injection by auto-injection device to manual injection (each injection separated by 28 days)

Clinical Trial Description

A single-center, open-label, 2-period, 2-sequence, 2-treatment, randomized, crossover study. After a screening period of up to 21 days before dosing, 36 eligible men and women will be assigned to receive a 50-mg subcutaneous (SC) dose of etanercept administered by each of 2 methods of injection (Treatment A: administration by auto-injector device; and Treatment B: administration by manual injection) on separate occasions in an order determined by a randomization list (randomized 1:1 to sequence). Treatment administrations will be separated by a minimum of 28 days (maximum of 36 days). Subjects will be required to remain resident during the 72-hours after dosing in each period. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Healthy Men and Women

Clinical Trial Details

NCT number	NCT02588534
Study type	Interventional
Source	Amgen
Contact
Status	Completed
Phase	Phase 1
Start date	August 2004
Completion date	October 2004

View Details

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