HealthyNCT05300087
Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
A study testing Albuterol Sulfate Inhalation Aerosol 108mcg per actuation and Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation in people with Healthy, run by Intech Biopharm Ltd. at 1 site in Taiwan.
Trial summary
The primary objective of the study was to assess the bioequivalence between the test product (Albuterol Sulfate inhalation aerosol 108mcg per actuation) and the reference product (Proair HFA [albuterol sulfate] Inhalation Aerosol 90mcg per actuation) under fasting conditions. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Albuterol Sulfate Inhalation Aerosol 108mcg per actuation and Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Feb 2022to 26 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers, aged 20-60, inclusive.
- BMI of 18.0-30.0 kg/m², inclusive. The body weight should be over 50 kg, inclusive. (BMI will be calculated as weight in kilogram [kg]/height in meters² [m²]).
- Healthy or non-clinical significant (NCS), according to the medical history, ECG, chest X-ray and physical examination as determined by the Principal Investigator/Sub-Investigator.
- Systolic blood pressure between 90-139 mmHg, inclusive, and diastolic blood pressure between 50-90 mmHg, inclusive, and pulse rate between 50-100 bpm, inclusive and temperature between 35.0-37.4℃.
- Screening laboratory values within reference range or NCS as determined by the Principal Investigator/Sub-Investigator.
- Ability to comprehend and be informed of the nature of the study, as assessed by clinical staff. Capable of giving written informed consent prior to receiving any study medication. Must be able to communicate effectively with clinical staff.
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- Willing to fast for at least 14 hours and to consume standard meals.
- Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
- Agree not to have a tattoo, body piercing, or any invasive procedure and blood donation until the end of the study.
- Never-smokers; or former smokers who have smoked ≥ 100 cigarettes in their lifetime and have not consumed any tobacco or tobacco containing products for at least 12 months prior to screening.
- Subjects who are non-asthmatic, defined as no clinical history of asthma, allergy or atopy.
- Able to perform special breathing using nebulizer correctly as per the required standard.
- Subjects must fulfill at least one of the following:
- Be surgically sterile for a minimum of 6 months;
- Post-menopausal for a minimum of 1 year;
- Agree to avoid pregnancy and use medically an acceptable method of contraception from screening day until 30 days after the study ends (last study procedure).
Who cannot join
- Known history or presence of any clinically significant hepatic (e.g. active liver disease, hepatic impairment), renal/genitourinary (e.g. renal impairment), gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine (e.g. hypothyroidism), immunological, musculoskeletal (e.g. myopathy, rhabdomyolysis), neurological, psychiatric, dermatological, hematological disease, or any other medical conditions, unless determined as not clinically significant by the Principal Investigator/Sub-Investigator.
- Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the Principal Investigator/Sub-Investigator.
- Presence of any significant physical or organ abnormality as determined by the Principal Investigator/Sub-Investigator.
- A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, tetrahydrocannabinol), breath alcohol test. Positive pregnancy test for female subjects.
- Known history or presence of:
- Alcohol abuse within one year prior to first drug administration;
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- Drug abuse or dependence;
- Hypersensitivity or idiosyncratic reaction to albuterol, its excipients, and/or related substances;
- Allergy to standardized meal provided by site and/or presence of any dietary restrictions;
- Intolerance to and/or difficulty in blood sampling through venipuncture.
- Abnormal diet patterns (for any reason) during the 4 weeks preceding the study, including fasting, high protein diets etc.
- Except for screening procedures, blood donation that results in blood loss of not more than 250 ml in the past 2 months prior to first dosing; blood loss of more than 250 ml within 3 months prior to first dosing.
- Donation of plasma by plasmapheresis within 7 days prior to first drug administration.
- Individuals who receives an investigational drug from 2 months prior to first drug administration.
- Consumption of products containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing and products containing grapefruit and/or pomelo (shown to inhibit cytochrome P450 [CYP] 3A4 activity) within 10 days prior to first drug administration.
- Use of any medication, including oral multivitamins, herbal and/or dietary supplements within 30 days prior to first drug administration (except topical agents without systemic absorption as determined by the Principal Investigator/Sub-Investigator).
- Females taking oral or transdermal hormonal contraceptives within 30 days prior to first drug administration.
- Females having used implanted, injected, intravaginal, or intrauterine hormonal contraceptive within 6 months prior to first drug administration.
- Individuals having undergone any major surgery within 6 months prior to the start of the study, unless deemed otherwise by Principal Investigator/Sub-Investigator.
- Using tobacco products, nicotine products (patches, gum etc.) within 6 months prior to first drug administration.
- Lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-dose, Open-label, Two-way Crossover Pivotal Study to Assess the Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation (MDI, eq. to Albuterol 90mcg/Puff) and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation (MDI, eq. to Albuterol 90mcg/Puff) in Healthy Volunteers Under Fasting Conditions
The primary objective of the study was to assess the bioequivalence between the test product (Albuterol Sulfate inhalation aerosol 108mcg per actuation) and the reference product (Proair HFA [albuterol sulfate] Inhalation Aerosol 90mcg per actuation) under fasting conditions. Bioequivalence would be demonstrated if the 90% confidence interval for the ratios of geometric means for AUC(0-t), AUC(0-inf), and Cmax between test products and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.
Read the detailed description
A single-dose, randomized, open-label, two-period, two-sequence, two-treatment, single-centre, two-way crossover bioequivalence study of Albuterol Sulfate inhalation aerosol 108mcg per actuation (equivalent to 90mcg of Albuterol) and Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation was carried out under fasting conditions in healthy adults, aged 20-60 years. For each period, 60 subjects were planned to receive a single dose of albuterol inhalation aerosol (2 puffs) according to the pre-determined randomization scheme. Venous blood of each subject was drawn 22 times over the period of 24 hours. Plasma samples were collected and analysed for albuterol concentrations by LC-MS/MS. For each subject, there were 2 dosing periods, separated by a 14-day washout period. During the study, standardized meals were provided to all subjects when institutionalized.
- Conditions
- Healthy
- Being tested
- Albuterol Sulfate Inhalation Aerosol 108mcg per actuation, Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol Sulfate Inhalation Aerosol 108mcg per actuationDrug
Also called Albuterol 90mcg/puff
MDI, 2 puffs, single dose, fasting
Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuationDrug
Also called Albuterol 90mcg/puff
MDI, 2 puffs, single dose, fasting
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Albuterol Sulfate Inhalation Aerosol Receives: Drug: Albuterol Sulfate Inhalation Aerosol 108mcg per actuation |
| Reference Group | Active comparator | Proair HFA (albuterol sulfate) Inhalation Aerosol Receives: Drug: Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The maximal observed plasma concentration of Albuterol Sulfate.
Measured: 0 hour (pre-dose), as well as at 2, 5, 10, 15, 20, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
AUC(0-t)
Area under the concentration time curve from time zero until the last measurable concentration or last sampling time t, whichever occurs first.
Measured: 0 hour (pre-dose), as well as at 2, 5, 10, 15, 20, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
AUC(0-inf)
Area under the concentration time curve from time zero to infinity.
Measured: 0 hour (pre-dose), as well as at 2, 5, 10, 15, 20, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Secondary outcomes (4)
Tmax
Time when the maximal plasma concentration is observed.
Measured: 0-24 hours
T1/2
Terminal elimination half-life, estimated as ln(2)/λ.
Measured: 0-24 hours
Kel(λ)
Terminal elimination rate constant, estimated by linear regression analysis of the terminal portion of the ln-concentration vs. time plot.
Measured: 0-24 hours
Mean Residence Time (MRT)
Mean residence time (MRT) is calculated by the area under the first moment curve dividing by area under the concentration time curve
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start24 Feb 2022
- Primary completion25 Apr 2022
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intech Biopharm Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chao-Hsien Chen, MD, Principal investigator, Tamshui Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300087
- Sponsor's protocol ID
- TW21-8077
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2022
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-dose, Open-label, Two-way Crossover Pivotal Study to Assess the Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation (MDI, eq. to Albuterol 90mcg/Puff) and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation (MDI, eq. to Albuterol 90mcg/Puff) in Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05300087
- Acronym / sponsor ID
- TW21-8077
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Intech Biopharm Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Posted 25 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study was to assess the bioequivalence between the test product (Albuterol Sulfate inhalation aerosol 108mcg per actuation) and the reference product (Proair HFA [albuterol sulfate] Inhalation Aerosol 90mcg per actuation) under fasting conditions. Bioequivalence would be demonstrated if the 90% confidence interval for the ratios of geometric means for AUC(0-t), AUC(0-inf), and Cmax between test products and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.
Detailed description
A single-dose, randomized, open-label, two-period, two-sequence, two-treatment, single-centre, two-way crossover bioequivalence study of Albuterol Sulfate inhalation aerosol 108mcg per actuation (equivalent to 90mcg of Albuterol) and Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation was carried out under fasting conditions in healthy adults, aged 20-60 years. For each period, 60 subjects were planned to receive a single dose of albuterol inhalation aerosol (2 puffs) according to the pre-determined randomization scheme. Venous blood of each subject was drawn 22 times over the period of 24 hours. Plasma samples were collected and analysed for albuterol concentrations by LC-MS/MS. For each subject, there were 2 dosing periods, separated by a 14-day washout period. During the study, standardized meals were provided to all subjects when institutionalized.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Albuterol Sulfate Inhalation Aerosol 108mcg per actuationAlbuterol Sulfate Inhalation Aerosol |
| Reference Group | Active comparator | Drug: Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuationProair HFA (albuterol sulfate) Inhalation Aerosol |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Healthy male and female volunteers, aged 20-60, inclusive.
- BMI of 18.0-30.0 kg/m², inclusive. The body weight should be over 50 kg, inclusive. (BMI will be calculated as weight in kilogram [kg]/height in meters² [m²]).
- Healthy or non-clinical significant (NCS), according to the medical history, ECG, chest X-ray and physical examination as determined by the Principal Investigator/Sub-Investigator.
- Systolic blood pressure between 90-139 mmHg, inclusive, and diastolic blood pressure between 50-90 mmHg, inclusive, and pulse rate between 50-100 bpm, inclusive and temperature between 35.0-37.4℃.
- Screening laboratory values within reference range or NCS as determined by the Principal Investigator/Sub-Investigator.
Key exclusion criteria (21 listed)
- Known history or presence of any clinically significant hepatic (e.g. active liver disease, hepatic impairment), renal/genitourinary (e.g. renal impairment), gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine (e.g. hypothyroidism), immunological, musculoskeletal (e.g. myopathy, rhabdomyolysis), neurological, psychiatric, dermatological, hematological disease, or any other medical conditions, unless determined as not clinically significant by the Principal Investigator/Sub-Investigator.
- Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the Principal Investigator/Sub-Investigator.
- Presence of any significant physical or organ abnormality as determined by the Principal Investigator/Sub-Investigator.
- A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, tetrahydrocannabinol), breath alcohol test. Positive pregnancy test for female subjects.
- Known history or presence of:
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 |
|---|---|---|
| Albuterol Sulfate Inhalation Aerosol 108mcg per actuationAlso: Albuterol 90mcg/puffMDI, 2 puffs, single dose, fasting | Drug | Test Group |
| Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuationAlso: Albuterol 90mcg/puffMDI, 2 puffs, single dose, fasting | Drug | Reference Group |
Primary outcome
Cmax
Time frame: 0 hour (pre-dose), as well as at 2, 5, 10, 15, 20, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
The maximal observed plasma concentration of Albuterol Sulfate.
AUC(0-t)
Time frame: 0 hour (pre-dose), as well as at 2, 5, 10, 15, 20, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Area under the concentration time curve from time zero until the last measurable concentration or last sampling time t, whichever occurs first.
AUC(0-inf)
Time frame: 0 hour (pre-dose), as well as at 2, 5, 10, 15, 20, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Area under the concentration time curve from time zero to infinity.
4 secondary outcomes
Tmax
Time frame: 0-24 hours
T1/2
Time frame: 0-24 hours
Kel(λ)
Time frame: 0-24 hours
Mean Residence Time (MRT)
Time frame: 0-24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Chao-Hsien Chen, MD principal investigator
Tamshui Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albuterol Sulfate Inhalation Aerosol 108mcg per actuation and Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation in people with Healthy, run by Intech Biopharm Ltd. at 1 site in Taiwan.
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 16 inclusion and 21 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: finished, as of the sponsor's last update on 18 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 Taiwan. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax (time frame: 0 hour (pre-dose), as well as at 2, 5, 10, 15, 20, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16 and 24 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 18 Mar 2024.