Bioequivalence Study of Lidocaine Prilocaine Cream, Phase 1, Apr 27
ClinicalTrials.gov Studies
Summary
A bioequivalence study comparing a test formulation of Lidocaine and Prilocaine Cream (Haisco Pharmaceutical Group Co., Ltd.) against the reference product EMLA® (AstraZeneca) in healthy adult subjects under fasting conditions. The single-center Phase 1 trial registered as NCT07551713 on ClinicalTrials.gov evaluates whether the two formulations are bioequivalent and assesses safety outcomes.
“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”
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What changed
This document registers a Phase 1 bioequivalence clinical trial on ClinicalTrials.gov. The study compares a generic lidocaine-prilocaine cream formulation against AstraZeneca's reference product EMLA® to evaluate pharmacokinetic equivalence and safety in healthy adult subjects under fasting conditions.
Affected parties include pharmaceutical manufacturers developing or seeking approval for generic topical anesthetic formulations. The trial results may inform Abbreviated New Drug Application (ANDA) submissions or similar generic drug approval pathways. Sponsors of reference-listed drugs and generic competitors should monitor bioequivalence data for this product category.
Archived snapshot
Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Bioequivalence Study of Lidocaine and Prilocaine Cream in Healthy Chinese Subjects
Phase 1 NCT07551713 Kind: PHASE1 Apr 27, 2026
Abstract
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
Conditions: Healthy
Interventions: Tested Lidocaine and Prilocaine Cream, Reference Lidocaine and Prilocaine Cream (EMLA®)
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