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Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects

2019-11-11 17:49:13 | BioPortfolio

Summary

This is a single-center, open-label, single-dose study to evaluate the safety, pharmacokinetics in healthy subjects

Description

This is a phase I, open-label, single-dose in healthy subjects conducted at single center.The objectives are to evaluate the metabolic and safety profile of EXPAREL®. Each volunteer will receive one dose of the investigational drug via subcutaneous injection at multiple points during the study period. Study duration is around 54 days, including screening, confinement, ambulatory visit and a phone follow up.

Study Design

Conditions

Healthy Subjects

Intervention

Bupivacaine liposome injectable suspension

Status

Not yet recruiting

Source

Nuance Pharma (shanghai) Co., Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-11T17:49:13-0500

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Medical and Biotech [MESH] Definitions

Positive test results in subjects who do not possess the attribute for which the test is conducted. The labeling of healthy persons as diseased when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)

Negative test results in subjects who possess the attribute for which the test is conducted. The labeling of diseased persons as healthy when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)

Books intended for use in the study of specific subjects, containing systematic presentation of the principles and essential knowledge of the subjects.

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