U.S., May 1 -- ClinicalTrials.gov registry received information related to the study (NCT07560150) titled 'Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog(R) After Single-Dose Subcutaneous Administration to Healthy Volunteers' on April 24.
Brief Summary: This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamic (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
Study Start Date: April 06
Study Type: INTERVENTIONAL
Condition:
Pharmacokinetics
Pharmacodyn...