A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot) - Trial NCT06326671
Access comprehensive clinical trial information for NCT06326671 through Pure Global AI's free database. This Phase 1 trial is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and is currently Recruitment Completed. The study focuses on Chronic Obstructive Pulmonary Disease. Target enrollment is 39 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Timeline & Enrollment
Phase 1
Feb 28, 2024
Apr 01, 2024
Primary Outcome
Peak concentration (Cmax),Area under the plasma concentration versus time curve (AUC) 0-t,Area under the plasma concentration versus time curve (AUC) 0-∞
Summary
Primary Objective: To evaluate the pharmacokinetics of 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:
 18mcg, manufactured by Boehringer Ingelheim Pharmaceuticals, Inc) by oral inhalation of
 single dose in healthy participants under fasting conditions.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06326671
Non-Device Trial