NCT06487416

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

A Single-Center, Open-Label, Randomized, Single-Dose, Two-Period, Two-Sequence, Crossover Trial to Assess the Bioequivalence of Test Product Tiotropium Bromide Inhalation Powder (Strength: 18 mcg) and Reference Product (Spiriva®Handihaler®, Strength: 18 mcg) in Healthy Adult Participants Under Fasting Conditions

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Tiotropium Bromide Inhalation Powder	By binding to M3 receptors, the action of acetylcholine is blocked to relieve spasm of bronchial smooth muscle.
DRUG	Spiriva®Handihaler®	By binding to M3 receptors, the action of acetylcholine is blocked to relieve spasm of bronchial smooth muscle.

Timeline

• Start date: 2024-06-10
• Primary completion: 2024-08-01
• Completion: 2024-10-01
• First posted: 2024-07-05
• Last updated: 2024-07-05

Locations

1 site across 1 country: China