Green (Sustainable) VENTOLIN - Pharmacokinetics (PK) Study in Healthy Participants
NCT ID: NCT05791565
Last Updated: 2024-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2023-04-03
2023-05-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Salbutamol HFA-152a MDI followed by Salbutamol HFA-134a MDI
Participants will receive Salbutamol HFA-152a MDI in treatment period 1 followed by Salbutamol HFA-134a MDI in treatment period 2. There will be a minimum washout period of 72 hours between each treatment period.
Salbutamol HFA-152a
Salbutamol HFA-152a will be administered.
Salbutamol HFA-134a
Salbutamol HFA-134a will be administered.
Salbutamol HFA-134a MDI followed by Salbutamol HFA-152a MDI
Participants will receive Salbutamol HFA-134a MDI in treatment period 1 followed by Salbutamol HFA-152a MDI in treatment period 2. There will be a minimum washout period of 72 hours between each treatment period.
Salbutamol HFA-152a
Salbutamol HFA-152a will be administered.
Salbutamol HFA-134a
Salbutamol HFA-134a will be administered.
Interventions
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Salbutamol HFA-152a
Salbutamol HFA-152a will be administered.
Salbutamol HFA-134a
Salbutamol HFA-134a will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
55 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Groningen, , Netherlands
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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219430
Identifier Type: -
Identifier Source: org_study_id
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