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NCT06326671Recruitment Completed

A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot)

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 (Pilot)
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Phase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Chronic Obstructive Pulmonary Disease
Drug/Device/Intervention
Tiotropium Bromide Inhalation Powder
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Location
Zhengzhou, China
Timeline & enrollment
Phase
Phase 1
Start date
Feb 28, 2024
End date
Apr 01, 2024
Enrollment
39 participants
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
Other chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease, unspecifiedOther specified chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease with acute exacerbation, unspecifiedChronic obstructive pulmonary disease with acute lower respiratory infection
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06326671
Type
Non-Device Trial
About this record

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.