An Relative Bioavailability Study of BH006 for Injection in Healthy Subjects

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).

Timeline

Start

2024-05

Primary completion

2024-09

Completion

2024-12

Drugs

Indications

No indication recorded.