Overview

A Trial to Assess the Bioequivalence of Tiotropium Bromide Inhalation Powder in Healthy Adult Participants Under Fasting Conditions

Status:
ACTIVE_NOT_RECRUITING
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
Summary
Primary Objective: To evaluate the pharmacokinetics and bioequivalence of the test products Tiotropium Bromide Inhalation Powder (Strength: 18 mcg; manufactured by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.) and reference products Tiotropium Bromide Inhalation Powder (Spiriva®Handihaler®, Strength: 18 mcg, manufactured by Boehringer Ingelheim Pharma GmbH and CO.KG) by oral inhalation in healthy participants under fasting conditions. Secondary Objective: To assess the safety of the test products Tiotropium Bromide Inhalation Powder (Strength: 18 mcg) and reference products Tiotropium Bromide Inhalation Powder (Spiriva®Handihaler®, Strength: 18 mcg) in healthy participants.
Phase:
PHASE1
Details
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.