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An Relative Bioavailability Study of BH006 for Injection in Healthy Subjects

Bioavailability Clinical Trial

Official title:
An Open-label, Randomized, Single-dose, Two-period Cross-over Study to Evaluate the Relative Bioavailability Between BH006 for Injection Per the Intended Dosage Regimen and Fosaprepitant and Palonosetron in Healthy Subjects

Clinical Trial Summary

The study is an open label, randomized, balanced, two period, two sequence, crossover, single dose, relative bioavailability study in healthy subjects.Each subject, meeting all the inclusion criteria and none of the exclusion criteria, will receive test product or reference product in a crossover manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 15 (Period II).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06427681
Study type Interventional
Source Zhuhai Beihai Biotech Co., Ltd
Contact Xiaohua Wei, PMD
Phone +86 13500248359
Email xhwei@bayhibiotech.com
Status Not yet recruiting
Phase Early Phase 1
Start date May 2024
Completion date December 2024
View Details
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