clinical trial · NCT06326671
A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot)
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·phase1·unknown·n = 39
Chronic Obstructive Pulmonary DiseaseTiotropium Bromide Inhalation PowderSpiriva HandiHaler
brief 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.
started
Feb 28, 2024
primary completion
Mar 1, 2024
completion
Apr 1, 2024
last updated
Mar 29, 2024
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 (Pilot)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol