Search for a trial

Single center, randomized, double-blind, 3-period, 3 treatments, 3 way crossover pharmacokinetics (PK)/pharmacodynamics (PD) trial to assess PK, PD, safety and tolerability of MYL-1401H after single subcutaneous injection at one dose level (2 mg) comparing to an EU and US marketed drug product (NEULASTA®) in healthy volunteers.

The purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…

A Phase 1 Study to Compare the Pharmacokinetics of CAL-101 Capsules to Tablets in Healthy Male Subjects.

Primary: to evaluate the pharmacokinetics of a single 100 mg dose of CAL-101 administered as a capsule (unmicronized formulation), a capsule (micronized formulation) or a tablet in normal healthy male subjectsSecondary: to evaluate the safety of a…