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Pharmacokinetic, Safety and Tolerability Study of Altebrel in Healthy Male Subjects

NCT03273088 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-09-19

No results posted yet for this study

Summary

This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate Altebrel relative to etanercept reference product (Enbrel®) and evaluate safety and tolerability of Altebrel, in a crossover fashion in healthy male volunteers after administration of a single dose (25 mg) of etanercept.

The primary objective of this study is to demonstrate that the PK of Altebrel is similar to its originator, Enbrel®, as assessed by the area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax.

The secondary objectives of the study are:

To further compare the PK of Altebrel and Enbrel®. To assess the safety of Altebrel.

Conditions

  • Phase 1
  • Bioequivalence

Interventions

DRUG

Etanercept

A single dose of etanercept (25mg/0.5ml prefilled syringe) was administered subcutaneously to healthy subjects.

Sponsors & Collaborators

  • AryoGen Pharmed Co.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-12-04
Primary Completion
2017-03-15
Completion
2017-03-15

Countries

  • Iran

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 NCT03273088 on ClinicalTrials.gov