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Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers

NCT03822884 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-02-12

Study results available
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Summary

Pharmacokinetic/Pharmacodynamic Study of 3 Epoetin Alfa Formulations in Single Subcutaneous Doses Administered to Healthy Volunteers

SPONSOR Biosidus S.A.

Conditions

Interventions

DRUG

Epoetin Alfa 40000 UNT/ML

40.000 UI subcutaneous single dose

Sponsors & Collaborators

  • Bio Sidus SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2016-09-30
Completion
2016-12-31

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Entities

Diseases

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 NCT03822884 on ClinicalTrials.gov