Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers

NCT03822884 Phase 1 COMPLETED Results posted

Pharmacokinetic/Pharmacodynamic Study of 3 Epoetin Alfa Formulations in Single Subcutaneous Doses Administered to Healthy Volunteers SPONSOR Biosidus S.A.

Details

Lead sponsor	Bio Sidus SA
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2016-09
Completion	2016-12

Conditions

• Anemia

Interventions

• Epoetin Alfa 40000 UNT/ML

Primary outcomes

• AUC0-t — 120 h
  AUC0-t: Area under the serum concentration curve from time 0 to time t (in this case, 120 hours).
• AUC0-∞ — 120hr
  AUC0-∞: Area under the serum concentration curve resulting from extrapolation from time 0 to time ∞.
• Cmax — 120hr
  Cmax: maximum serum concentration of epoetin alfa.
• Tmax — 120hr
  Tmax: time to the maximum serum concentration of epoetin alfa