Bioequivalence Study of Methacholine Chloride

Bioequivalence Study of Methacholine for Inhalation

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.

Study Overview

• Status: Completed
• Conditions: Healthy People
• Intervention / Treatment: Drug: Test preparation：Methylcholine chloroacetate for inhalation; Drug: Reference preparation：Methylcholine chloroacetate for inhalation（(Provocholin）

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusions Criteria

1. Male or female healthy subjects aged 18 to 50 years old (including 18 and 50 years old).
2. Male subjects weigh no less than 50 kg, female subjects weigh no less than 45 kg; and body mass index (BMI) = weight (kg) / height 2 (m2), and body mass index is within the range of 18.5~27.0 (including critical values).

3) Normal pulmonary function test (FEV1 ≥ 80% predicted value, FEV1/FVC ≥ 0.7), FEV1 decline rate after inhalation of saline is no more than 20%, and methacholine chloride provocation test is negative.

4. Sign the informed consent form before the experiment and fully understand the content, process and possible adverse reactions of the experiment.

5. Subjects can communicate well with researchers and understand and comply with the requirements of this study.

Exclusions Criteria

1. Ask for any diseases that might interfere with the test results
2. Have a history of drug/food allergy
3. blood collection difficulties or can not tolerate indwelling needle blood collection
4. Patients who had surgery within 4 weeks prior to the trial or planned to have surgery during the study period
5. Patients who have used any drug within 2 weeks before the test
6. Subjects have participated in any drug or medical device clinical study within 3 months prior to screening (except those who failed screening or did not receive any experimental drug).
7. Blood loss or blood donation exceeding 400 mL in the 3 months prior to screening (excluding female menstrual blood loss), or who intend to donate blood during the trial or within 1 month after the trial.
8. pregnant and lactating women, or pregnancy test positive.
9. Male subjects (or their partners) or female subjects had unprotected sex or had a pregnancy plan from 1 week before screening to 3 months after the end of the trial, and were unwilling to use one or more non-drug contraceptive methods (such as total abstinence, contraceptive rings, partner ligation, etc.) during the trial.
10. Previous history of drug abuse/drug use; Or test positive for drug abuse.
11. the diet has special requirements, can not comply with the unified diet.
12. Those who had a smoking history within 6 months before the test, smoked more than 5 cigarettes per day, or were unwilling to give up smoking during the test, or had positive results of nicotine screening.
13. Alcoholics or regular drinkers in the six months prior to the trial, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or breath-positive for alcohol.
14. Eating a diet within 48 hours prior to taking the study drug that may affect the metabolism of the drug in the body, smoking, drinking behavior, or other diet that the investigator believes may affect the absorption, distribution, metabolism, or excretion of the drug.
15. Physical examination, electrocardiogram, laboratory examination, vital signs and other tests related to the test were judged by the investigator to be abnormal and clinically significant.
16. Acute illness or concomitant medication occurred from the screening stage to the study medication.
17. Subjects who may not be able to complete the study for other reasons or who the investigator believes should not be included

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test preparation：Methylcholine chloroacetate for inhalation; Inhale methacholine solution for 1 minute	Drug: Test preparation：Methylcholine chloroacetate for inhalation; Cholinergic agonists
Active Comparator: Reference preparation：Methylcholine chloroacetate for inhalation（(Provocholin）; Inhale methacholine solution for 1 minute	Drug: Reference preparation：Methylcholine chloroacetate for inhalation（(Provocholin）; Cholinergic agonists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Concentration	The highest plasma drug concentration that can be achieved after administration	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 when the time is from 0 to the last time point selected（AUC0-t）	The area under the blood concentration time curve from 0 to t after administration	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 during time from 0 to infinity（AUC0-∞）	Area under the blood concentration time curve after medication	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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Actual): February 3, 2024
• Study Completion (Actual): February 3, 2024

Study Registration Dates

• First Submitted: November 30, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Estimated): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 8, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antimetabolites; Nootropic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Lipotropic Agents; Choline
• Other Study ID Numbers: TQC3610-BE-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No