Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT06487416
A Trial to Assess the Bioequivalence of Tiotropium Bromide Inhalation Powder in Healthy Adult Participants Under Fasting Conditions
A Phase 1 study testing Tiotropium Bromide Inhalation Powder and Spiriva®Handihaler® in people with Chronic Obstructive Pulmonary Disease (COPD), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Tiotropium Bromide Inhalation Powder and Spiriva®Handihaler®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2024to Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Consumption of any products containing alcohol within 48 h before the initial administration, or a positive result of the alcohol breath test;
- A positive result of the drug abuse test, or a history of drug abuse in the past 5 years, or intake of any narcotic drugs within 3 months prior to the trial;
- A positive result of the pregnancy test, or in lactation during screening or the test period for female participants;
- History of fainting at needle or blood;
- Not tolerable on venipuncture, or a history of difficulty in venous blood collection;
- Special requirements and unable to follow the unified diet, or lactose/galactose intolerant;
- Unable to participate in this trial for participants' own reasons;
- Participants who cannot use the powder inhalers correctly after training;
- Other conditions in which participants are not suitable for the trial determined by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000
About this study
Official title: A Single-Center, Open-Label, Randomized, Single-Dose, Two-Period, Two-Sequence, Crossover Trial to Assess the Bioequivalence of Test Product Tiotropium Bromide Inhalation Powder (Strength: 18 mcg) and Reference Product (Spiriva®Handihaler®, Strength: 18 mcg) in Healthy Adult Participants Under Fasting Conditions
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.
- Being tested
- Tiotropium Bromide Inhalation Powder, Spiriva®Handihaler®
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium Bromide Inhalation PowderDrug
By binding to M3 receptors, the action of acetylcholine is blocked to relieve spasm of bronchial smooth muscle.
Spiriva®Handihaler®Drug
By binding to M3 receptors, the action of acetylcholine is blocked to relieve spasm of bronchial smooth muscle.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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® Receives: Drug: Spiriva®Handihaler® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
Maximum plasma drug concentration
Measured: 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
Measured: 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
Measured: 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)
The time to maximum plasma concentration (observed)
Measured: 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)
Elimination half-life of plasma concentration
Measured: 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)
Terminal elimination rate constant
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start10 Jun 2024
- Primary completionAug 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487416
- Sponsor's protocol ID
- STXA-BE-04
- Status last verified
- May 2024
- First submitted
- 28 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Randomized, Single-Dose, Two-Period, Two-Sequence, Crossover Trial to Assess the Bioequivalence of Test Product Tiotropium Bromide Inhalation Powder (Strength: 18 mcg) and Reference Product (Spiriva®Handihaler®, Strength: 18 mcg) in Healthy Adult Participants Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06487416
- Acronym / sponsor ID
- STXA-BE-04
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiotropium Bromide Inhalation Powder | Experimental | Drug: Tiotropium Bromide Inhalation PowderTest 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 |
| Spiriva®Handihaler® | Experimental | Drug: Spiriva®Handihaler®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® |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiotropium Bromide Inhalation PowderBy binding to M3 receptors, the action of acetylcholine is blocked to relieve spasm of bronchial smooth muscle. | Drug | Tiotropium Bromide Inhalation Powder |
| Spiriva®Handihaler®By binding to M3 receptors, the action of acetylcholine is blocked to relieve spasm of bronchial smooth muscle. | Drug | Spiriva®Handihaler® |
Primary outcome
Peak concentration (Cmax)
Time frame: 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
Maximum plasma drug concentration
Area under the plasma concentration versus time curve (AUC) 0-t
Time frame: 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
Plasma concentration-time curve from zero to the time of the last measurable time point t
Area under the plasma concentration versus time curve (AUC) 0 - infinity
Time frame: 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-time curve from zero to infinity
3 secondary outcomes
The time to maximum plasma concentration (Tmax)
Time frame: 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)
Time frame: 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)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tiotropium Bromide Inhalation Powder and Spiriva®Handihaler® in people with Chronic Obstructive Pulmonary Disease (COPD), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak concentration (Cmax) (time frame: 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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.