Last updated: 05/20/2024 11:30:14
Green (Sustainable) VENTOLIN – Pharmacokinetics (PK) study in healthy participants
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A single dose two-way cross-over study in healthy participants to compare the pharmacokinetics (PK) of salbutamol administered via metered dose inhalers containing propellants HFA-152a and HFA-134a
Trial description: This study will be conducted to compare the PK of salbutamol administered via metered dose inhalers (MDI) containing propellants 1,1-difluroethane (HFA-152a) and 1,1,1,2-tetrafluoroethane (HFA-134a) in healthy participants.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Area under the plasma concentration-time curve (AUC) up to 30 minutes post-dose (AUC[0-30 minute]) of salbutamol
Timeframe: Pre-dose and at 3, 5, 10, 15, 20 and 30 minutes post-dose on Days 1 and 4
AUC from time 0 to infinity (AUC[0-inf]) of salbutamol
Timeframe: Up to Day 5
AUC from time 0 to time t (AUC[0-t]) of salbutamol
Timeframe: Up to Day 5
Maximum observed plasma concentration (Cmax) of salbutamol
Timeframe: Up to Day 5
Secondary outcomes:
Time to Cmax (Tmax) of salbutamol
Timeframe: Up to Day 5
Apparent terminal phase half-life (t1/2) of salbutamol
Timeframe: Up to Day 5
Minimum serum potassium level following administration of salbutamol
Timeframe: Up to Day 5
Weighted mean (0-4 hours) serum potassium level following administration of salbutamol
Timeframe: Pre-dose and at 15 minutes, 30 minutes, 1, 1.5, 2 and 4 hours post-dose on Days 1 and 4
Maximum heart rate following administration of Salbutamol
Timeframe: Up to Day 5
Weighted mean (0-4 hours) heart rate following administration of Salbutamol
Timeframe: Pre-dose and at 15 minutes, 30 minutes, 1, 1.5, 2 and 4 hours post-dose on Days 1 and 4
Maximum corrected QT (QTc) interval following administration of Salbutamol
Timeframe: Up to Day 5
Weighted mean (0-4 hours) QTc interval following administration of Salbutamol
Timeframe: Pre-dose and at 15 minutes, 30 minutes, 1, 1.5, 2 and 4 hours post-dose on Days 1 and 4
Number of participants with non-serious adverse events and serious adverse events
Timeframe: Up to Day 5
Absolute values of Electrocardiogram (ECG) parameters: PR interval, QRS duration, QT interval and corrected QT (QTc) interval (Milliseconds)
Timeframe: Up to Day 5
Change from Baseline in ECG parameters: PR interval, QRS duration, QT interval and QTc interval (Milliseconds)
Timeframe: Baseline and up to Day 5
Absolute values of ECG parameter: Heart rate (Beats per minute)
Timeframe: Up to Day 5
Change from Baseline in ECG parameters: Heart rate (Beats per minute)
Timeframe: Baseline and up to Day 5
Absolute values of hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count (Giga cells per liter)
Timeframe: Up to Day 5
Absolute values of hematology parameter: Red blood cell (RBC) count (Trillion cells per liter)
Timeframe: Up to Day 5
Absolute values of hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters)
Timeframe: Up to Day 5
Absolute values of hematology parameter: Mean corpuscular hemoglobin (MCH) (Picograms)
Timeframe: Up to Day 5
Absolute values of hematology parameter: Percentage of reticulocytes (Percentage of reticulocytes)
Timeframe: Up to Day 5
Absolute values of hematology parameter: Hemoglobin (Grams per Liter)
Timeframe: Up to Day 5
Absolute values of hematology parameter: Hematocrit (Proportion of red blood cells in blood)
Timeframe: Up to Day 5
Absolute values of clinical chemistry parameters: Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK) (International units per Liter)
Timeframe: Up to Day 5
Absolute values of clinical chemistry parameters: direct bilirubin, total bilirubin and Creatinine (Micromoles per liter)
Timeframe: Up to Day 5
Absolute values of clinical chemistry parameter: Total protein (Grams per liter)
Timeframe: Up to Day 5
Absolute Values for Chemistry Parameters: Glucose, Calcium, Sodium, Potassium, Blood Urea Nitrogen (Millimoles per liter)
Timeframe: Up to Day 5
Number of participants with abnormal urinalysis parameters by Dipstick Method
Timeframe: Up to Day 5
Absolute values of diastolic blood pressure (DBP) and systolic blood pressure (SBP) (Millimeters of mercury [mmHg])
Timeframe: Up to Day 5
Absolute values of pulse rate (Beats per minute)
Timeframe: Up to Day 5
Interventions:
Drug: Salbutamol HFA-152a
Drug: Salbutamol HFA-134a
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
2023-21-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
salbutamol
Collaborators
Not applicable
Study date(s)
April 2023 to May 2023
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 Years
Accepts healthy volunteers
Yes
- Aged 18 to 55 years, inclusive, at screening
- Body mass index 18.0 to 30.0 kilograms per meter square (kg/m^2), inclusive, at screening
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
- History or presence of any form of asthma, including childhood asthma and exercise induced asthma
Inclusion and exclusion criteria
Inclusion criteria:
- Aged 18 to 55 years, inclusive, at screening
- Body mass index 18.0 to 30.0 kilograms per meter square (kg/m^2), inclusive, at screening
- Weight: greater than or equal to (>=)50 kg
- At screening, females must not be pregnant or lactating, or of non-childbearing potential
- Female participants of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception
- Male participants, if not surgically sterilized, must agree to use adequate contraception
- Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, electrocardiogram, and vital signs, as judged by the investigator
- Willing and able to sign the informed consent form
Exclusion criteria:
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
- History or presence of any form of asthma, including childhood asthma and exercise induced asthma
- Current enrollment or past participation in this clinical study
- Participants with clinically significant abnormalities
- A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse
- Positive nasopharyngeal polymerase chain reaction test for severe acute respiratory syndrome-corona virus type 2 (SARS-CoV-2) on Day -1 or any known close contact with a person who tested positive for SARS-CoV-2 or with a coronavirus disease 2019 participant within 2 weeks prior to admission
- Impairment which would prevent the correct and consistent use of an MDI, as determined by the investigator
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2023-21-05
Actual study completion date
2023-21-05
Plain language summaries
Summary of results in plain language
Available language(s): English, Dutch
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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