Staccato® Granisetron Single Dose PK

Summary

This study was conducted in 2 parts in separate treatment groups of healthy volunteers. Part A of the study was double-blind, randomized, and placebo-controlled; Part B is open label. The primary objectives for each part were as follows: Part A: 1. To examine the tolerability and safety of single ascending doses up to 3 mg of AZ-010 (Staccato Granisetron) in healthy volunteers 2. To characterize the pharmacokinetics (PK) of single ascending doses up to 3 mg of AZ-010 in healthy volunteers Part B: 1\. To compare the PK and safety of a single dose of 1 mg of AZ-010 with that of 1 mg granisetron hydrochloride intravenous (IV) injection in healthy volunteers. The 2 parts to the study were performed sequentially.

Timeline

Start

2019-11-04

Primary completion

2020-01-10

Completion

2020-01-31

Drugs

Indications

No indication recorded.