Bioequivalence Study of Methacholine Chloride

Phase 4

Completed

• Conditions: Healthy People
• Interventions: Drug: Test preparation：Methylcholine chloroacetate for inhalation; Drug: Reference preparation：Methylcholine chloroacetate for inhalation（(Provocholin）

• Registration Number: NCT06730620
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

This trial was divided into two parts. The first part was the PK bioequivalence study in healthy people, which was designed as a single-dose, randomized, open, four-cycle, two-sequence, fully repeated crossover design, and planned to enroll 20 subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-29
• Primary Completion: 2024-02-03
• Study Completion: 2024-02-03
• Study First Submitted: 2024-11-30
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-08
• Last Update Submitted: 2024-12-08
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test preparation：Methylcholine chloroacetate for inhalation	Test preparation：Methylcholine chloroacetate for inhalation	Inhale methacholine solution for 1 minute
Reference preparation：Methylcholine chloroacetate for inhalation（(Provocholin）	Reference preparation：Methylcholine chloroacetate for inhalation（(Provocholin）	Inhale methacholine solution for 1 minute

Primary Outcome Measures

Name	Time	Method
Peak Concentration	Within 60 minutes before administration and within 3 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 6 hours, and 8 hours after administration	The highest plasma drug concentration that can be achieved after administration
The area under the blood concentration time curve when the time is from 0 to the last time point selected（AUC0-t）	Within 60 minutes before administration and within 3 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 6 hours, and 8 hours after administration	The area under the blood concentration time curve from 0 to t after administration
The area under the blood concentration time curve during time from 0 to infinity（AUC0-∞）	Within 60 minutes before administration and within 3 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 6 hours, and 8 hours after administration	Area under the blood concentration time curve after medication

Trial Locations

Locations (1)

China-japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China