Trial Outcomes & Findings for Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers (NCT NCT03822884)
NCT ID: NCT03822884
Last Updated: 2020-02-12
Results Overview
AUC0-t: Area under the serum concentration curve from time 0 to time t (in this case, 120 hours).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
120 h
Results posted on
2020-02-12
Participant Flow
Participant milestones
| Measure |
Hemax PFS - Hemax - Eprex
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
2. nd Period: 40,000 UI (SC) of Hemax (lyophilized)
3. rd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
|
Hemax PFS - Eprex - Hemax
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
2. nd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
3. rd Period: 40,000 UI (SC) of Hemax (lyophilized)
|
Hemax - Hemax PFS - Eprex
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Hemax (lyophilized)
2. nd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
3. rd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
|
Hemax - Eprex - Hemax PFS
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Hemax (lyophilized)
2. nd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
3. rd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
|
Eprex - Hemax PFS - Hemax
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
2. nd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
3. rd Period: 40,000 UI (SC) of Hemax (lyophilized)
|
Eprex - Hemax - Hemax PFS
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
2. nd Period: 40,000 UI (SC) of Hemax (lyophilized)
3. rd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Hemax PFS - Hemax - Eprex
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
2. nd Period: 40,000 UI (SC) of Hemax (lyophilized)
3. rd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
|
Hemax PFS - Eprex - Hemax
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
2. nd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
3. rd Period: 40,000 UI (SC) of Hemax (lyophilized)
|
Hemax - Hemax PFS - Eprex
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Hemax (lyophilized)
2. nd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
3. rd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
|
Hemax - Eprex - Hemax PFS
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Hemax (lyophilized)
2. nd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
3. rd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
|
Eprex - Hemax PFS - Hemax
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
2. nd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
3. rd Period: 40,000 UI (SC) of Hemax (lyophilized)
|
Eprex - Hemax - Hemax PFS
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
2. nd Period: 40,000 UI (SC) of Hemax (lyophilized)
3. rd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Hemax PFS - Hemax - Eprex
n=4 Participants
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
2. nd Period: 40,000 UI (SC) of Hemax (lyophilized)
3. rd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
|
Hemax PFS - Eprex - Hemax
n=4 Participants
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
2. nd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
3. rd Period: 40,000 UI (SC) of Hemax (lyophilized)
|
Hemax - Hemax PFS - Eprex
n=4 Participants
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Hemax (lyophilized)
2. nd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
3. rd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
|
Hemax - Eprex - Hemax PFS
n=4 Participants
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Hemax (lyophilized)
2. nd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
3. rd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
|
Eprex - Hemax PFS - Hemax
n=4 Participants
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
2. nd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
3. rd Period: 40,000 UI (SC) of Hemax (lyophilized)
|
Eprex - Hemax - Hemax PFS
n=4 Participants
Volunteers in this groups received
1. st Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)
2. nd Period: 40,000 UI (SC) of Hemax (lyophilized)
3. rd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.25 years
STANDARD_DEVIATION 12.71 • n=93 Participants
|
44.25 years
STANDARD_DEVIATION 0.96 • n=4 Participants
|
41.50 years
STANDARD_DEVIATION 13.77 • n=27 Participants
|
37.50 years
STANDARD_DEVIATION 8.96 • n=483 Participants
|
32.25 years
STANDARD_DEVIATION 12.69 • n=36 Participants
|
41.50 years
STANDARD_DEVIATION 10.66 • n=10 Participants
|
39.54 years
STANDARD_DEVIATION 10.37 • n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
|
Weight
|
76.00 kg
STANDARD_DEVIATION 14.02 • n=93 Participants
|
72.00 kg
STANDARD_DEVIATION 8.68 • n=4 Participants
|
74.00 kg
STANDARD_DEVIATION 6.32 • n=27 Participants
|
74.25 kg
STANDARD_DEVIATION 8.73 • n=483 Participants
|
69.25 kg
STANDARD_DEVIATION 11.93 • n=36 Participants
|
72.00 kg
STANDARD_DEVIATION 10.20 • n=10 Participants
|
72.92 kg
STANDARD_DEVIATION 9.36 • n=115 Participants
|
|
Height
|
177.50 cm
STANDARD_DEVIATION 15.20 • n=93 Participants
|
127.25 cm
STANDARD_DEVIATION 4.79 • n=4 Participants
|
173.25 cm
STANDARD_DEVIATION 3.95 • n=27 Participants
|
171.00 cm
STANDARD_DEVIATION 13.74 • n=483 Participants
|
171.00 cm
STANDARD_DEVIATION 6.83 • n=36 Participants
|
170.50 cm
STANDARD_DEVIATION 8.54 • n=10 Participants
|
172.58 cm
STANDARD_DEVIATION 9.02 • n=115 Participants
|
|
Body Mass Index
|
24.01 kg/m^2
STANDARD_DEVIATION 2.03 • n=93 Participants
|
24.21 kg/m^2
STANDARD_DEVIATION 1.63 • n=4 Participants
|
24.67 kg/m^2
STANDARD_DEVIATION 2.21 • n=27 Participants
|
25.44 kg/m^2
STANDARD_DEVIATION 1.33 • n=483 Participants
|
23.39 kg/m^2
STANDARD_DEVIATION 2.29 • n=36 Participants
|
24.64 kg/m^2
STANDARD_DEVIATION 1.33 • n=10 Participants
|
24.39 kg/m^2
STANDARD_DEVIATION 1.76 • n=115 Participants
|
PRIMARY outcome
Timeframe: 120 hAUC0-t: Area under the serum concentration curve from time 0 to time t (in this case, 120 hours).
Outcome measures
| Measure |
Hemax® PFS 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Hemax® 40,000 UI
n=23 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Erypo ® 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
|---|---|---|---|
|
AUC0-t
|
37440.71 mUI*h/mL
Standard Deviation 16821.67
|
34483.73 mUI*h/mL
Standard Deviation 13513.69
|
41150.49 mUI*h/mL
Standard Deviation 17095.44
|
PRIMARY outcome
Timeframe: 120hrAUC0-∞: Area under the serum concentration curve resulting from extrapolation from time 0 to time ∞.
Outcome measures
| Measure |
Hemax® PFS 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Hemax® 40,000 UI
n=23 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Erypo ® 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
|---|---|---|---|
|
AUC0-∞
|
42487.04 mUI*h/mL
Standard Deviation 19533.78
|
36907.41 mUI*h/mL
Standard Deviation 14363.66
|
43978.39 mUI*h/mL
Standard Deviation 18786.74
|
PRIMARY outcome
Timeframe: 120hrCmax: maximum serum concentration of epoetin alfa.
Outcome measures
| Measure |
Hemax® PFS 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Hemax® 40,000 UI
n=23 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Erypo ® 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
|---|---|---|---|
|
Cmax
|
853.11 mUI / ml
Standard Deviation 386.49
|
808.29 mUI / ml
Standard Deviation 338.10
|
913.07 mUI / ml
Standard Deviation 429.19
|
PRIMARY outcome
Timeframe: 120hrTmax: time to the maximum serum concentration of epoetin alfa
Outcome measures
| Measure |
Hemax® PFS 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Hemax® 40,000 UI
n=23 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Erypo ® 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
|---|---|---|---|
|
Tmax
|
14.17 h
Standard Deviation 5.53
|
15.04 h
Standard Deviation 5.13
|
14.96 h
Standard Deviation 5.16
|
SECONDARY outcome
Timeframe: 120hrReticulocyte count by flow cytometry, as a surrogate marker of the pharmacodynamics of erythropoietin. Maximum reticulocyte concentration achieved.
Outcome measures
| Measure |
Hemax® PFS 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Hemax® 40,000 UI
n=23 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Erypo ® 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
|---|---|---|---|
|
Reticulocyte Response: Cmax
|
1.23 mUI / ml
Standard Deviation 0.46
|
1.33 mUI / ml
Standard Deviation 0.49
|
1.31 mUI / ml
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 120hrOutcome measures
| Measure |
Hemax® PFS 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Hemax® 40,000 UI
n=23 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Erypo ® 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
|---|---|---|---|
|
Reticulocyte Response: AUC 0-120h
|
341.65 mUI*h/mL
Standard Deviation 162.98
|
344.49 mUI*h/mL
Standard Deviation 132.89
|
345.58 mUI*h/mL
Standard Deviation 150.13
|
SECONDARY outcome
Timeframe: 120hrNumber of patients with antidrug antibodies after 3 months. Anti-erythropoietin antibodies screening was done using immunoprecipitation on the sample collected prior to the first dose of the first phase of the trial and on the 504-hour sample of the third phase
Outcome measures
| Measure |
Hemax® PFS 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Hemax® 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Erypo ® 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
|---|---|---|---|
|
ADAs
Anti-erythropoietin antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
|
ADAs
No anti-erythropoietin antibodies detected
|
24 Participants
|
24 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 120hrNumber of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Outcome measures
| Measure |
Hemax® PFS 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Hemax® 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Erypo ® 40,000 UI
n=24 Participants
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
|---|---|---|---|
|
Adverse Events
Asthenia
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Adverse Events
Myalgia
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Adverse Events
Pruritus of trunk
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Generalized myalgia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Adverse Events
Arthralgia
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Adverse Events
Dorsal myalgia
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Events
Fracture
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Events
Pyrosis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Vomiting
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Adverse Events
Diarrhea
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Events
Nausea
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
No adverse events registered
|
13 Participants
|
17 Participants
|
10 Participants
|
|
Adverse Events
Headache
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Hemax® PFS 40,000 UI
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Hemax® 40,000 UI
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Erypo ® 40,000 UI
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hemax® PFS 40,000 UI
n=24 participants at risk
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Hemax® 40,000 UI
n=24 participants at risk
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Erypo ® 40,000 UI
n=24 participants at risk
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Severe low back pain
|
4.2%
1/24 • Number of events 1 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
Other adverse events
| Measure |
Hemax® PFS 40,000 UI
n=24 participants at risk
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Hemax® 40,000 UI
n=24 participants at risk
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
Erypo ® 40,000 UI
n=24 participants at risk
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose
|
|---|---|---|---|
|
General disorders
Asthenia
|
12.5%
3/24 • Number of events 3 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
12.5%
3/24 • Number of events 3 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
20.8%
5/24 • Number of events 5 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
3/24 • Number of events 3 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
8.3%
2/24 • Number of events 2 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
|
Skin and subcutaneous tissue disorders
Pruritus of trunk
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
4.2%
1/24 • Number of events 1 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
|
Musculoskeletal and connective tissue disorders
Generalized myalgia
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
4.2%
1/24 • Number of events 1 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
4.2%
1/24 • Number of events 1 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
8.3%
2/24 • Number of events 2 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
|
Musculoskeletal and connective tissue disorders
Dorsal myalgia
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
4.2%
1/24 • Number of events 1 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
4.2%
1/24 • Number of events 1 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
4.2%
1/24 • Number of events 1 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
|
General disorders
Headache
|
8.3%
2/24 • Number of events 2 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
|
Gastrointestinal disorders
Pyrosis
|
4.2%
1/24 • Number of events 1 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Number of events 1 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
4.2%
1/24 • Number of events 1 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
4.2%
1/24 • Number of events 1 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
4.2%
1/24 • Number of events 1 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
|
General disorders
Nausea
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
4.2%
1/24 • Number of events 1 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
0.00%
0/24 • The security profile was determined in all 3 periods of drug administration. All the volunteers were planned to received 3 doses of rhEPO. The duration of all clinical phase was 75 days. so, safety information was collected during 75 days.
Adverse Event Reporting was conducted according to the regulation 6677/2010 (Section B.7) of the National Regulatory Agency
|
Additional Information
Clinical Trial Manager - Dr. Roberto A. Diez
Biosidus S.A.
Phone: +5411 4909 8000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI is not allowed to disclose any confidential information of the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER