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ACTIVE NOT RECRUITING
NCT06487416
PHASE1

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

Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

186

Start Date

2024-06-10

Completion Date

2024-10

Last Updated

2024-07-05

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China