NCT01685333View on ClinicalTrials.gov

PK and PD Crossover Study After Single Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant Epoetin and Eprex, in Healthy Subjects.

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Healthy
Interventions
DRUG

Epoetin Alfa

Intravenous single-dose administration of 100 IU/kg of the test drug (Human Recombinant Epoetin) in the first period and intravenous single-dose administration of 100 IU/kg of the comparator drug (Eprex) in the second period, after 23-30 days of washout, or vice-versa.

Trial Locations (1)

13276-245

LAL Clinica, Valinhos

All Listed Sponsors
lead

Azidus Brasil

INDUSTRY

NCT01685333 - PK and PD Crossover Study After Single Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant Epoetin and Eprex, in Healthy Subjects. | Biotech Hunter | Biotech Hunter