Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation in Healthy Volunteers Under Fasting Conditions

NCT04803734 | Completed Results

• 1 other identifier: TW20-4502
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to assess the bioequivalence between the test products (Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation) and the reference products (Proair HFA \[Albuterol Sulfate\] Inhalation Aerosol 90 mcg Per Actuation) in healthy volunteers under fasting conditions. The test product was considered bioequivalent to the reference product if the T/R ln-transformed AUC(0-t), AUC(0-inf), and Cmax were within 80.00-125.00% of those of the reference.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Cmax

  The maximal observed plasma concentration of Albuterol Sulfate.

  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.

  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.

  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

  0-24 hours

• T1/2

  0-24 hours

• Kel(λ)

  0-24 hours

• Mean Residence Time (MRT)

  0-24 hours

Study Arms (2)

Test Group

EXPERIMENTAL

Albuterol Sulfate inhalation aerosol

Drug: Albuterol Sulfate inhalation aerosol 108mcg per actuation

Reference Group

ACTIVE COMPARATOR

Proair HFA (albuterol sulfate) Inhalation Aerosol

Drug: Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation

Interventions

Albuterol Sulfate inhalation aerosol 108mcg per actuation DRUG

MDI, 2 puffs, single dose, fasting

Also known as: Albuterol 90mcg/puff

Test Group

Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation DRUG

MDI, 2 puffs, single dose, fasting

Also known as: Albuterol 90mcg/puff

Reference Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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, 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.
• 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 other 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;

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Intech Biopharm Ltd.: lead

Study Sites (1)

Tamshui Mackay Memorial Hospital

New Taipei City, 251, Taiwan

Location

MeSH Terms

Interventions

Albuterol

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Sabina Chien
• Organization: Intech Biopharm Ltd.

sabina.i198@intechbiopharm.com

+886-2-7721-8877

Study Officials

• Wen-Kuei Chang, MD

  Tamshui Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 18, 2021
• Study Start: March 19, 2021
• Primary Completion: May 10, 2021
• Study Completion: May 14, 2021
• Last Updated: March 18, 2024
• Results First Posted: September 25, 2023

Record last verified: 2024-03

Locations

TW (1)