Spots Global Cancer Trial Database for Bioequivalence Trial of Luitpold Azacitidine Versus Vidaza® in Patients With Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia or Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Bioequivalence Trial of Luitpold Azacitidine Versus Vidaza® in Patients With Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia or Chronic Lymphocytic Leukemia
Official Title: Blinded Cross-over Bioequivalence Trial of Luitpold Azacitidine Versus Vidaza® in Patients With Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia or Chronic Lymphocytic Leukemia
Study ID: NCT01290302
Study Description
Brief Summary: The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of subcutaneous Vidaza® versus subcutaneous Luitpold Azacitidine.
Detailed Description: To assess the bioequivalence of Vidaza® and Luitpold Azacitidine pharmacokinetics, in terms of Cmax, AUC0-t and AUC0-∞, following SC administration. To assess the comparative safety of Vidaza® versus Luitpold Azacitidine during the 2 day study period.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Luitpold Pharmaceuticals, Inc., Norristown, Pennsylvania, United States
Contact Details
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