Anaemia Clinical Trial
Official title:
A Phase I Single Centre Open Label Trial to Investigate the Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta (NeoRecormon®) in Healthy Japanese and Caucasian Male Subjects
A study to see how a single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy Japanese compares with a single subcutaneous dose of Epoetin beta (NeoRecormon®) in Caucasian Male subjects. Each subject received a single subcutaneous dose of 50IU/kg of NeoRecormon Multidose solution on Day 1.
Ethnic comparison studies are becoming common research requirements in order to identify
differences in response to drugs in various ethnic populations. This study will investigate
the pharmacokinetic parameters and pharmacodynamic response in healthy Caucasian and
Japanese male subjects after a single subcutaneous administration of 50IU/kg Epoetin beta
This is a Phase I single centre, open label trial to investigate the bioequivalence of a
single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy Japanese and Caucasian
Male subjects.
The primary objectives are 1) to establish the pharmacokinetic parameters of Epoetin beta in
healthy Japanese and Caucasian males, and 2) to compare the pharmacokinetic parameters
AUCinf and Cmax in healthy Japanese and Caucasian males. The secondary objective is to
establish the pharmacodynamic parameters of a single dose of Epoetin beta in healthy
Japanese and Caucasian males.
Subjects will receive a single subcutaneous administration of 50IU/kg on one occasion only.
The planned study duration is approximately 1 month.
;
Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05682326 -
Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)
|
Phase 3 | |
| Completed |
NCT03400033 -
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)
|
Phase 3 | |
| Completed |
NCT02879305 -
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
|
Phase 3 | |
| Completed |
NCT02876835 -
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
|
Phase 3 | |
| Terminated |
NCT02801162 -
Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard
|
N/A | |
| Completed |
NCT02288637 -
Evaluation of a Novel Long Lasting Insecticidal Net and Indoor Residual Spray Product
|
N/A | |
| Completed |
NCT00276224 -
Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia
|
N/A | |
| Completed |
NCT00857077 -
Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana
|
N/A | |
| Completed |
NCT06080555 -
Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia
|
Phase 1 | |
| Completed |
NCT01977573 -
A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)
|
Phase 2 | |
| Completed |
NCT02243306 -
Study to Assess the Pharmacokinetics of GSK1278863 in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis
|
Phase 1 | |
| Completed |
NCT01111630 -
Study of Erythropoietin (EPO) Administration Schedule
|
Phase 4 | |
| Completed |
NCT00140517 -
Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance
|
N/A | |
| Completed |
NCT03239522 -
Absorption and Elimination of Radiolabeled Daprodustat
|
Phase 1 | |
| Completed |
NCT01376232 -
Study to Assess the Pharmacokinetics of GSK1278863A Coadministered With a High Fat Meal or an Inhibitor of CYP2C8 (Gemfibrozil)
|
Phase 1 | |
| Completed |
NCT02019719 -
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Japanese Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease
|
Phase 2 | |
| Completed |
NCT02969655 -
A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)
|
Phase 3 | |
| Completed |
NCT02637102 -
The UK CAVIAR Study
|
||
| Completed |
NCT01454752 -
Intermittent Parasite Clearance (IPC) in Schools: Impact on Malaria, Anaemia and Cognition
|
N/A | |
| Completed |
NCT01136850 -
Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea
|
Phase 3 |