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NCT01664221
Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Eritromax (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Multiple Dose, Intravenous Administration in Healthy Subjects: a Randomized Parallel Study.
Phase 1 trial testing Epoetin Alfa in Healthy in 80 participants. Status unknown.
1 October 2013
Quick facts
| Lead sponsor | Azidus Brasil |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 February 2013 |
| Primary completion | 1 October 2013 |
| Estimated completion | 1 October 2013 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Epoetin Alfa (EPOETIN ALFA) — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Azidus Brasil — full company profile →
Who can join
Adults 20 to 55, male only, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
rHuEPO serum concentration
Time frame: 1, 8, 15, 19, 22 and 26 days after first 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 administration -
plasma reticulocyte count.
Time frame: 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.
Sponsor's own description
The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects following administration of multiple intravenous dose. The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the test drug Eritromax® marketed by Blau Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a multiple intravenous administration during 4 weeks of 100 IU/kg in healthy subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01664221
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Azidus Brasil trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01664221 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azidus Brasil
- Last refreshed: 10 August 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01664221.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing