- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01664195
PK and PD Study After Single Dose, Intravenous Administration of Two Epoetin Alfa, Eritromax and Eprex, in Healthy Subjects
Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Eritromax (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Single Dose, Intravenous Administration in Healthy Subjects: a Randomized Study.
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
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São Paulo
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Valinhos, São Paulo, Brasil, 13276-245
- LAL Clínica
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Agree to all the purposes of the study by signing and dating the Informed Consent;
- Male, aged between 20 and 55 years, clinically healthy;
- BMI between 18.5 and 30;
- Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%;
- VCM between 82 and 98, HBMC between 26 and 34, platelets between 150,000 and 400,000 units per mL. and WBC between 3,500 to 10,500 units per ml and no atypical cells.
- Human serum ferritin between 36-262 mcg / L;
- Counting of reticulocytes in peripheral blood ≤ 3%;
- Serum erythropoietin < 30 mIU / mL.
Exclusion Criteria:
- Participation in clinical trials in the 12 months preceding the survey;
- Body weight > 100 kg;
- Presence of iron deficiency anemia;
- Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
- Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
- Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
- Hormone therapy in the period of 02 months preceding the beginning of the practical phase (administration of the drug) of the study;
- Administration of any drug in the 02 weeks prior to the start of the practical period of the study;
- Clinical history of autoimmune or hereditary anemia;
- Clinical history of chronic bleeding;
- Clinical history of acute bleeding in the 30 days preceding the beginning of practical phase of the study (administration of the drug);
- Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation;
- Current or previous history (less than 12 months) of illicit drug abuse and / or tobacco and / or alcohol or having consumed alcohol within 48 hours prior to the practical study periods (administration of the drug);
- Prior therapies with erythropoietin;
- Albumin below 3.5 g/dL or higher than 4.8 g/dL;
- Signs or clinical history of bone marrow aplasia;
- History and clinical or laboratory liver disease;
- History and clinical or laboratory nephropathy;
- Principal Investigator of the study criteria.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Group A
Epoetin alfa Test drug in the first period and comparator drug in the second period.
|
Intravenous single-dose administration of 100 IU/kg of the test drug (Eritromax) 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.
Andre navn:
|
Annen: Group B
Epoetin alfa Comparator Drug in the first period and test drug in the second period
|
Intravenous single-dose administration of 100 IU/kg of the test drug (Eritromax) 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
rHuEPO serum concentration
Tidsramme: 0, 10, 20, 30, 40, 50 minutes 1, 2, 4, 6, 8, 10, 12, 24, 36 e 48 hours after drug administration
|
Time frame on days 1, 8, 19 and 22: -10min, 0h, 5min, 15min, 30min, 45min, 1,5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h and 12h after administration; Time frame on day 26: -10min, 0h, 5min, 15min, 30min, 45min, 1,5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 36h after last drug administration. |
0, 10, 20, 30, 40, 50 minutes 1, 2, 4, 6, 8, 10, 12, 24, 36 e 48 hours after drug administration
|
plasma reticulocyte count
Tidsramme: 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26 and 29 days after first administration of the drug
|
Time frame on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26: 10 minutes before drug administration. Time frame on day 29: 72 hours +/- 2 hours after last drug administration. |
1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26 and 29 days after first administration of the drug
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EPOBLA0312IV-I
- Version 1 01/03/2012 (Annen identifikator: LAL Clinica)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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