A Trial to Assess the Bioequivalence of Tiotropium Bromide Inhalation Powder in Healthy Adult Participants Under Fasting Conditions

NCT06487416 | Active Not Recruiting Phase 1

• 1 other identifier: STXA-BE-04
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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 (Spiriva®Handihaler®, Strength: 18 mcg, manufactured by Boehringer Ingelheim Pharma GmbH and CO.KG) 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 (Spiriva®Handihaler®, Strength: 18 mcg) in healthy participants.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (3)

• Peak concentration (Cmax)

  Maximum plasma drug concentration

  Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minuets, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose

• Area under the plasma concentration versus time curve (AUC) 0-t

  Plasma concentration-time curve from zero to the time of the last measurable time point t

  Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minuets, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose

• Area under the plasma concentration versus time curve (AUC) 0 - infinity

  Area under the plasma concentration-time curve from zero to infinity

  Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minuets, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose

Secondary Outcomes (3)

• The time to maximum plasma concentration (Tmax)

  Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minuets, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose

• The elimination half-life (t1/2)

  Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minuets, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose

• Terminal elimination rate constant (Kel)

  Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minuets, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose

Study Arms (2)

Tiotropium Bromide Inhalation Powder

EXPERIMENTAL

Test Product Tiotropium Bromide Inhalation Powder (Strength: 18 microgram (mcg), as tiotropium, equivalent to 22.5 microgram of tiotropium bromide monohydrate). The subjects randomly received single oral dose of tiotropium bromide inhaling powder

Drug: Tiotropium Bromide Inhalation Powder

Spiriva®Handihaler®

EXPERIMENTAL

Reference Product (Spiriva®Handihaler®, Strength: 18 microgram, as tiotropium, equivalent to 22.5 microgram of tiotropium bromide monohydrate). The subjects randomly received single oral dose of Spiriva®Handihaler®

Drug: Spiriva®Handihaler®

Interventions

Tiotropium Bromide Inhalation Powder DRUG

By binding to M3 receptors, the action of acetylcholine is blocked to relieve spasm of bronchial smooth muscle.

Tiotropium Bromide Inhalation Powder

Spiriva®Handihaler® DRUG

By binding to M3 receptors, the action of acetylcholine is blocked to relieve spasm of bronchial smooth muscle.

Spiriva®Handihaler®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to give signed Informed Consent Form before the trial, and fully understand the trial content, process and possible adverse drug reactions (ADRs);
• Able to complete the trial in compliance with the protocol;
• Participants (including males) willing to adopt effective contraceptive methods and with no pregnancy plan from 14 days before screening to 3 months after the last scheduled visit;
• Males and females between 18 and 55 years old, inclusive;
• At least 50 kg for males, 45 kg for females, with a Body Mass Index (BMI) = Weight/Height2 (kg/m2) between 19.0-26.0 kg/m2, inclusive;
• No history of cardiac, hepatic, renal, ophthalmology and otorhinolaryngology, respiratory system, urogenital system, digestive tract, nervous system, mental and metabolic disorders, etc.

You may not qualify if:

• With ≥ 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial, or a positive result for urine nicotine test;
• Be allergic to tiotropium, atropine or its derivatives (e.g., ipratropium, oxitropium) or any excipient of tiotropium bromide inhalation powder; or allergic constitution (be allergic to two or more drugs, food and pollen allergy); or with specific allergy history (asthma, urticaria, eczema, etc.);
• A history of alcohol abuse (alcohol consumption of more than 14 units per week: 1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine);
• Blood donation or massive blood loss (≥400 mL) within 3 months before the initial administration; Or any blood donation plan from screening until 1 month after the last administration;
• Participants who have an acute upper respiratory tract infection within 2 weeks prior to receiving investigational product;
• History of any clinically significant diseases or any other diseases that could interfere with the study results, including but not limited to the circulatory system, gastrointestinal system, urinary system (such as history of prostate hypertrophy, bladder neck obstruction, urinary retention, etc.), respiratory system (such as acute onset of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary edema, pulmonary interstitial disease, bronchospastic pulmonary disease, bronchial asthma, etc.), ophthalmology (such as: glaucoma, etc.), nervous system, immune system, endocrine system, malignant tumor, mental and metabolic abnormalities; or with history of nasopharyngitis, throat ulcers, edema, or history of throat, tracheal/bronchial and lung surgery in the past;
• Participants who have Sjogren's syndrome and habitual constipation;
• Function test: the forced expiratory volume in one second measured value / the forced expiratory volume in one second predicted value ≤80% or the forced expiratory volume in one second / forced vital capacity ≤80%;
• Any prescription medication within 14 days before the initial administration;
• Any over-the-counter (OTC) medication or Chinese herbal medicine or health supplementary within 7 days before the initial administration;
• Consumption of any special diets (such as grapefruit), or strenuous exercise engagement, or other factors affecting drug absorption, distribution, metabolism and excretion within 7 days before the initial administration;
• Participation in other drug clinical trials within 3 months before the initial administration;
• Any clinically significant abnormality findings, as judged by a clinical physician, such as physical examination, vital signs, electrocardiogram, chest X-ray examination and laboratory tests;
• Positive results of hepatitis B surface antigen, hepatitis C antibody, and HIV antibody or syphilis;
• Consumption of chocolate or any food/beverage containing caffeine or rich in xanthine within 48 h before the initial administration;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233000, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: June 10, 2024
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-05

Locations

CN (1)