INTRODUCTION: India is one of the few countries where biosimilar enoxaparin is available for clinical use. Despite availability since past 4 to 5 years, there is a paucity of published literature regarding their biological activity. The aim of the current study is to compare the biological activity of an endogenously developed formulation of enoxaparin with the branded formulation. MATERIALS AND METHODS:Twelve healthy male volunteers received 1 subcutaneous injection of 2 different formulations of enoxaparin in a randomized, open-label, balanced, 2-treatment, 2-period, 2-sequence, cross-over study. The test formulation was Injection Troynoxa (enoxaparin sodium 40 mg/0.4 mL, Troikaa Pharmaceuticals Ltd., India) and reference formulation was Injection Clexane (enoxaparin sodium 40 mg/ 0.4 mL, Sanofi-Aventis, UK). The plasma anti-Xa activity and activated partial thromboplastin time (aPTT) were estimated on fully automated coagulometer predose and at 2, 4, 6, 8, and 10 hours following dosing with 40 mg/0.4 mL of enoxaparin. RESULTS: The results of mixed model analysis of repeated measures analysis of variance (ANOVA) for estimating difference between least square means of test and reference formulations, at all time points, showed no significant differences in anti-Xa activity and plasma aPTT levels. Both formulations were well tolerated and there were no bleeding episodes. CONCLUSION: After a single-dose injection in healthy participants, anti-Xa activities of 2 formulations of LMWH enoxaparin were comparable. No significant difference was observed in the mean plasma aPTT. It remains to be seen whether the 2 formulations would show comparable clinical efficacy.
RCT Entities:
INTRODUCTION: India is one of the few countries where biosimilar enoxaparin is available for clinical use. Despite availability since past 4 to 5 years, there is a paucity of published literature regarding their biological activity. The aim of the current study is to compare the biological activity of an endogenously developed formulation of enoxaparin with the branded formulation. MATERIALS AND METHODS: Twelve healthy male volunteers received 1 subcutaneous injection of 2 different formulations of enoxaparin in a randomized, open-label, balanced, 2-treatment, 2-period, 2-sequence, cross-over study. The test formulation was Injection Troynoxa (enoxaparin sodium 40 mg/0.4 mL, Troikaa Pharmaceuticals Ltd., India) and reference formulation was Injection Clexane (enoxaparin sodium 40 mg/ 0.4 mL, Sanofi-Aventis, UK). The plasma anti-Xa activity and activated partial thromboplastin time (aPTT) were estimated on fully automated coagulometer predose and at 2, 4, 6, 8, and 10 hours following dosing with 40 mg/0.4 mL of enoxaparin. RESULTS: The results of mixed model analysis of repeated measures analysis of variance (ANOVA) for estimating difference between least square means of test and reference formulations, at all time points, showed no significant differences in anti-Xa activity and plasma aPTT levels. Both formulations were well tolerated and there were no bleeding episodes. CONCLUSION: After a single-dose injection in healthy participants, anti-Xa activities of 2 formulations of LMWH enoxaparin were comparable. No significant difference was observed in the mean plasma aPTT. It remains to be seen whether the 2 formulations would show comparable clinical efficacy.