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This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence I (DRL, A, B) | Experimental | Patients will receive study drugs in the following cross-over sequence: DRL_PG, Pegfilgrastim Form A, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection. |
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| Treatment Sequence II (DRL, B, A) | Experimental | Patients will receive study drugs in the following cross-over sequence: DRL_PG, Pegfilgrastim Form B, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection. |
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| Treatment Sequence III (A, DRL, B) | Experimental | Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, DRL_PG, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection. |
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| Treatment Sequence IV (A, B, DRL) | Experimental | Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, Pegfilgrastim Form B, DRL_PG. Each drug is administered as a single, 6 mg, subcutaneous injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DRL_PG | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration | 105 days |
| AUC(0-inf) | Area under concentration-time curve extrapolated from time 0 to infinity | 105 days |
| AUC(0-t) | Area under concentration-time curve from time 0 to the time of the last quantifiable concentration | 105 days |
| Emax | Maximum observed effect | 105 days |
| AUEC(0-t) | Area under the effect time curve from time zero (predose) to last measured time | 105 days |
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Inclusion Criteria:
Healthy male and female subjects aged 18 to 55 years
A standardized body mass index
General good health as determined by the Investigator
Normal organ function as per the Investigator's judgement
Must be non-smokers, or ex-smokers who have not smoked within the previous 6 months from the screening visit
Female subjects must:
Male subjects must refrain from donating sperm or fathering a child during the study and until 3 months after the last study drug
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS Bio-Kinetic | Recruiting | Springfield | Missouri | 65802 | United States |
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| Treatment Sequence V (B, A, DRL) | Experimental | Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, Pegfilgrastim Form A, DRL_PG. Each drug is administered as a single, 6 mg, subcutaneous injection. |
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| Treatment Sequence VI (B, DRL, A) | Experimental | Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, DRL_PG, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection. |
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| Pegfilgrastim Form A | Biological |
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| Pegfilgrastim Form B | Biological |
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