Bioequivalence Study of a Generic Enoxaparin Sodium to Clexane® After Single Subcutaneous Dose in Healthy Human Subjects
Status:
Completed
Trial end date:
2021-03-11
Target enrollment:
Participant gender:
Summary
This is a single-dose, randomized, double-blind, two-period, two-treatment, two-sequence,
crossover, balanced, pharmacodynamic (PD) study with 7 days wash-out period. The objective of
this study is to assess the bioequivalence between the Enoxaparin (Venus Remedies Limited,
India) and its innovator product (Clexane®, Sanofi, Germany).