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Bioequivalence Study of Methacholine Chloride

NCT06730620 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-12-12

No results posted yet for this study

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.

Conditions

  • Healthy People

Interventions

DRUG

Test preparation：Methylcholine chloroacetate for inhalation

Cholinergic agonists

DRUG

Reference preparation：Methylcholine chloroacetate for inhalation（(Provocholin）

Cholinergic agonists

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    collaborator INDUSTRY

  • China-Japan Friendship Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2024-02-03
Completion
2024-02-03

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06730620 on ClinicalTrials.gov