Bioequivalence Study of Methacholine for Inhalation (pharmacodynamics)
NCT06725641 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2024-12-10
Summary
This trial was divided into two parts. This is the scecond part. The second part is the pharmacodynamic equivalence study of patients, which is a single-dose, randomized, open, two-cycle, two-sequence crossover design, and plans to enroll 40 subjects.
Conditions
Interventions
- DRUG
-
Test preparation:Methylcholine chloroacetate for inhalation
Cholinergic agonists
- DRUG
-
Reference preparation:Methylcholine chloroacetate for inhalation(Provocholine)
Cholinergic agonists
Sponsors & Collaborators
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
collaborator INDUSTRY -
China-Japan Friendship Hospital
lead OTHER
Principal Investigators
-
Ting Yang, Doctor · China-Japan Friendship Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-24
- Primary Completion
- 2024-10-22
- Completion
- 2024-10-26
Countries
- China
Study Locations
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