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Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application

NCT01141270 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2010-08-04

No results posted yet for this study

Summary

Comparative pharmacokinetics study after single subcutaneous application of AFOLIA and the reference product (Gonal-f®).

Objective: To demonstrate equivalence within the 80%-125% margin of the reference product for the area under the curve (AUC) of AFOLIA compared to (Gonal-f®).

Conditions

  • Healthy

Interventions

DRUG

AFOLIA

single sc injection, 225 IU

DRUG

Gonal-f

single sc injection, 225IU

Sponsors & Collaborators

  • Polymun Scientific GmbH

    lead INDUSTRY

Principal Investigators

  • Michael Wolzt, aoUniv.Prof. · Medical University Vienna

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-08-31
Completion
2010-07-31

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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 NCT01141270 on ClinicalTrials.gov