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COMPLETED
NCT07551713
PHASE1

Bioequivalence Study of Lidocaine and Prilocaine Cream in Healthy Chinese Subjects

Sponsor: Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

The test formulation (Lidocaine and Prilocaine Cream, Haisco Pharmaceutical Group Co., Ltd.) and the reference formulation (EMLA®, AstraZeneca) were applied to healthy adult subjects under fasting conditions to evaluate the bioequivalence and safety of the two formulations

Official title: Bioequivalence and Safety Study of Lidocaine and Prilocaine Cream in Healthy Chinese Subjects : A Randomized, Open-label, Single-dose, Two-period, Cross-over Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-06-11

Completion Date

2020-09-28

Last Updated

2026-04-27

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Tested Lidocaine and Prilocaine Cream

Under fasting conditions, 15 g of the test formulation (Lidocaine and Prilocaine Cream, Haisco Pharmaceutical Group Co., Ltd.) was applied to the anterior thigh of the subjects (over an area of 10 cm × 10 cm, totaling 100 cm2), with the administration completed within 5 minutes.

DRUG

Reference Lidocaine and Prilocaine Cream (EMLA®)

Under fasting conditions, 15 g of the reference formulation (EMLA®, AstraZeneca.) was applied to the anterior thigh of the subjects (over an area of 10 cm × 10 cm, totaling 100 cm2), with the administration completed within 5 minutes.

Locations (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, China