Chronic Obstructive Pulmonary DiseasePhase 1NCT06326671
A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot)
A Phase 1 study testing Tiotropium Bromide Inhalation Powder and Spiriva HandiHaler in people with Chronic Obstructive Pulmonary Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
Primary Objective: To evaluate the pharmacokinetics of 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: 18mcg, manufactured by Boehringer Ingelheim… 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
- 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
- 39 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2024to Apr 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 (included);
- 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 (included);
- 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
- Take ≥ 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial, or urine nicotine test is positive;
- Be allergic to tiotropium, atropine or its derivatives (e.g., ipratropium, oxitropium) or any excipient of tiotropium bromide inhalation sprays; 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, uroschesis, 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;
Show all 24Show fewer
- History of sicca syndrome or 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 hours before the initial administration;
- Consumption of any products containing alcohol within 48 hours 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 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 intolerance to lactose or galactose;
- Unable to participate in this trial for participants' own reasons;
- Participants who cannot control of powder inhaler oral inhalation 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
Henan (Zhengzhou) Zhonghui Cardiovascular Hospital
Zhengzhou, Henan, 450003
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 (Pilot)
Primary Objective: To evaluate the pharmacokinetics of 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: 18mcg, manufactured by Boehringer Ingelheim Pharmaceuticals, Inc) by oral inhalation of single dose in healthy participants under fasting conditions.
- Conditions
- Chronic Obstructive Pulmonary Disease
- 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
It's a generic product of Spiriva HandiHaler.
Spiriva HandiHalerDrug
Tiotropium Bromide Inhalation Powder RLD, which binds to M3 receptors, and blocks the action of acetylcholine to relieve spasm of bronchial smooth muscle.
| Study group | Role | What they receive |
|---|---|---|
| Test Product Tiotropium Bromide Inhalation Powder (Strength: 18 mcg) | Experimental | The subjects randomly received single oral inhalation dose of Tiotropium bromide inhaling powder generic product. Receives: Drug: Tiotropium Bromide Inhalation Powder |
| Reference Product (Spiriva®Handihaler®, Strength: 18 mcg) | Active comparator | The subjects randomly received single oral inhalation dose of the reference listed drug (RLD) 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 minutes, 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 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose
Area under the plasma concentration versus time curve (AUC) 0-∞
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 minutes, 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 minutes, 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 minutes, 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 minutes, 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 posted22 Mar 2024
- Study start28 Feb 2024
- Primary completionMar 2024 (estimated)
- Study completionApr 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 DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 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
- NCT06326671
- Sponsor's protocol ID
- STXA-BE-03
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 29 Mar 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 29 Mar 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 (Pilot)
- ClinicalTrials.gov ID
- NCT06326671
- Acronym / sponsor ID
- STXA-BE-03
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 22 Mar 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 of 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: 18mcg, manufactured by Boehringer Ingelheim Pharmaceuticals, Inc) by oral inhalation of single dose in healthy participants under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product Tiotropium Bromide Inhalation Powder (Strength: 18 mcg) | Experimental | Drug: Tiotropium Bromide Inhalation PowderThe subjects randomly received single oral inhalation dose of Tiotropium bromide inhaling powder generic product. |
| Reference Product (Spiriva®Handihaler®, Strength: 18 mcg) | Active comparator | Drug: Spiriva HandiHalerThe subjects randomly received single oral inhalation dose of the reference listed drug (RLD) 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 (included);
- 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 (included);
Key exclusion criteria (24 listed)
- Take ≥ 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial, or urine nicotine test is positive;
- Be allergic to tiotropium, atropine or its derivatives (e.g., ipratropium, oxitropium) or any excipient of tiotropium bromide inhalation sprays; 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 PowderIt's a generic product of Spiriva HandiHaler. | Drug | Test Product Tiotropium Bromide Inhalation Powder (Strength: 18 mcg) |
| Spiriva HandiHalerTiotropium Bromide Inhalation Powder RLD, which binds to M3 receptors, and blocks the action of acetylcholine to relieve spasm of bronchial smooth muscle. | Drug | Reference Product (Spiriva®Handihaler®, Strength: 18 mcg) |
Primary outcome
Peak concentration (Cmax)
Time frame: Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minutes, 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 minutes, 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-∞
Time frame: Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minutes, 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 minutes, 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 minutes, 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 minutes, 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 29 Mar 2024.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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, 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 29 Mar 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 minutes, 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 29 Mar 2024.