Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487416
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
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
Organization:
Chia Tai Tianqing Pharmaceutical Group Co Ltd
Study Overview
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 SpirivaHandihaler Strength 18 mcg in Healthy Adult Participants Under Fasting Conditions
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 SpirivaHandihaler Strength 18 mcg manufactured by Boehringer Ingelheim Pharma GmbH and COKG 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 SpirivaHandihaler Strength 18 mcg in healthy participants
Secondary Objective To assess the safety of the test products Tiotropium Bromide Inhalation Powder Strength 18 mcg and reference products Tiotropium Bromide Inhalation Powder SpirivaHandihaler Strength 18 mcg in healthy participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None