Bioavailability study of Enoxaparin Sodium Chemi (80 mg/0.8 mL) and Clexane (80 mg/0.8 mL) subcutaneous injection in healthy adults

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Healthy adults (n=47). Intervention: Chemi Enoxaparin vs. Clexane (80 mg/0.8 mL). Primary outcome: Anti-FXa activity AUC0-t (Geometric LS mean ratio 102.89%, 95% CI 100.67-105.15).

Q: What does this research mean for the field?

Chemi Enoxaparin is bioequivalent to Clexane, with the 95% CI of the geometric mean ratios for anti-FXa and anti-FIIa activity Cmax and AUC0-t falling entirely within the 80.00% to 125.00% bioequivalence limits. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

Salvatore Febbraro; Javier Leal Martínez-Bujanda; Concepción Nieto Magro; P. Bettica

doi:10.5414/cp204022

August 17, 2021International Journal of Clinical Pharmacology and TherapeuticsOpen Access

Bioavailability study of Enoxaparin Sodium Chemi (80 mg/0.8 mL) and Clexane (80 mg/0.8 mL) subcutaneous injection in healthy adults

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Key result

Chemi Enoxaparin was bioequivalent to Clexane, with the 95% CI of the geometric mean ratios for anti-FXa and anti-FIIa activity Cmax and AUC0-t falling entirely within the 80.00% to 125.00% bioequivalence limits.

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Why the study?

To compare the bioavailability of subcutaneous Chemi Enoxaparin with Clexane under fasting conditions in healthy subjects.

Does Chemi Enoxaparin show bioequivalence to Clexane when administered subcutaneously in healthy subjects?

Study Design

Type

RCT (n=47)

Blinding

Open-label

Randomization

Computer-generated randomization schedule

Multicenter

No

Structured PICO

Does Chemi Enoxaparin show bioequivalence to Clexane when administered subcutaneously in healthy subjects?

P

Population

47 healthy adults aged 18 to 55 years with a BMI of 18-30 kg/m2, evaluated in a single-dose crossover study.

I

Intervention

Chemi Enoxaparin (enoxaparin sodium) 80 mg/0.8 mL subcutaneous injection, single dose under fasting conditions.

C

Comparator

Clexane (enoxaparin sodium, reference drug) 80 mg/0.8 mL subcutaneous injection, single dose under fasting conditions.

O

Outcome

Anti-FIIa and anti-FXa Cmax and AUC0-t.surrogate

Main Result

Effect estimate: Geometric LS mean ratio 102.89% (95% CI 100.67-105.15)

Absolute Event Rate: 9.484% vs 9.218%

Chemi enoxaparin 80 mg subcutaneous injection is bioequivalent to the reference Clexane in healthy adults, with similar safety and tolerability profiles.

Limitations

Information on safety and tolerability from healthy subjects has limitations compared to actual clinical practice.
Open-label design, although laboratory staff were blinded to treatment.
information on safety and tolerability from healthy subjects has limitations

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Implication

Supports Chemi Enoxaparin substitution for Clexane; confirms bioequivalence for anti-FXa and anti-FIIa activity in healthy adults.

Abstract

OBJECTIVE: The present study compared the bioavailability of subcutaneous (s.c.) Chemi Enoxaparin with Clexane (80 mg/0.8 mL) under fasting conditions in healthy subjects. MATERIALS AND METHODS: was between 80.00 and 125.00%. The number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) was low, mostly of mild severity, and similar for both compounds. CONCLUSION: Chemi enoxaparin is bioequivalent to the reference enoxaparin, and both compounds show similar tolerability and safety profiles.

Discussion

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Cite This Study

Febbraro et al. (2021) conducted an RCT in Healthy adults (n=47). Chemi Enoxaparin vs. Clexane (80 mg/0.8 mL) was evaluated on Anti-FXa activity AUC0-t (Geometric LS mean ratio 102.89%, 95% CI 100.67-105.15). Chemi Enoxaparin was bioequivalent to Clexane, with the 95% CI of the geometric mean ratios for anti-FXa and anti-FIIa activity Cmax and AUC0-t falling entirely within the 80.00% to 125.00% bioequivalence limits.

synapsesocial.com/papers/6a1eaf4e99b676b6b9af2a5e https://doi.org/10.5414/cp204022

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Bioavailability study of Enoxaparin Sodium Chemi (80 mg/0.8 mL) and Clexane (80 mg/0.8 mL) subcutaneous injection in healthy adults

Figures

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Bioavailability study of Enoxaparin Sodium Chemi (80 mg/0.8 mL) and Clexane (80 mg/0.8 mL) subcutaneous injection in healthy adults

Figures

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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