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Trial record 75 of 865 for:    ALBUTEROL

In Vivo Investigation of Novel Nano-vesicles of Salbutamol Sulphate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03059017
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Mona Gamal Mohamed Afifi Arafa, British University In Egypt

Tracking Information
First Submitted Date  ICMJE February 15, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date February 23, 2017
Actual Study Start Date  ICMJE February 5, 2017
Actual Primary Completion Date February 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
The maximum plasma concentration (Cmax) [ Time Frame: Twenty Four Hours ]
The maximum concentration of Salbutamol Sulphate in human blood after time intervals 0, 30, 1,2, 3,4 , 5 & 6 hs will be calculated using validated using Excel software.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
The time required to reach maximum plasma (Tmax) [ Time Frame: Twenty Four Hours ]
Time taken for Salbutamol Sulphate to reach its maximum concentration in human blood & will be calculated using validated using Excel software
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 16, 2017)
The area under plasma concentration time curve (AUC) [ Time Frame: Twenty Four Hours ]
The integral in a plot of concentration of Salbutamol Sulphate in blood plasma against time.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE In Vivo Investigation of Novel Nano-vesicles of Salbutamol Sulphate
Official Title  ICMJE Novel Nano-vesicles of Salbutamol Sulphate in Metered Dose Inhalers: Formulation, Characterization, In Vitro and In Vivo Evaluation
Brief Summary The relative bioavailability of different salbutamol sulphate inhaler formulations will be studied in healthy male subjects according to the ethical regulations of World Medical Association Declaration of Helsinki (1996) after the approval of the ethical committee, Faculty of Pharmacy, The British University in Egypt.
Detailed Description

In this study, 20 healthy, non smoking, adult male volunteers (age: 30-45 years, weight: 65-80 kg) will carry out screening procedures which include instruction and practice with the placebo metered dose inhaler devices that will be used in the study. In addition, all subjects were fully informed in writing of the objectives and implications of the trial. No subject will be considered for the study if developed any symptoms of allergic disorders. Subjects will follow a normal diet and will not receive any other medications. Volunteers will be divided into two groups; each group contained 10 volunteers who will receive one formula of the selected formulae.

Each volunteer will inhale eight puffs (4 puffs at -5 min & 4 puffs at 0 min) which are equivalent to 0.8 mg of salbutamol sulphate . To inhale through metered dose inhalers, volunteers will be trained to exhale slowly to their residual volume (as far as comfortable), put the inhaler into their mouth and seal their lips round the mouth piece. Then they will be instructed to take a slow deep inspiration to their total lung capacity over approximately 5-10 seconds. At the end of each inhalation, they will hold their breath for 10 seconds and then breathe normally (Ball et al, 2002) . Three milliliters of blood will be withdrawn at 0, 0.5, 1, 2, 3, 4, 5 and 6 h after administration. The blood will be heparinized immediately and centrifuged at 3000 rpm for 10 minutes. The plasma samples will be stored at freeze temperature until analysis. Two different formulae will be compared during the first six hours following administration. The maximum plasma concentration (Cmax), the time required to reach maximum plasma concentration (Tmax) and the area under plasma concentration time curve (AUC) will be calculated using validated Excel software.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Volunteers will be divided into two groups; each group contained 10 volunteers who will receive one formula of the selected formulae.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Drug Effect
  • Pulmonary Disease
Intervention  ICMJE
  • Drug: Salbutamol Sulphate
    salbutamol sulphate packaged as aerosol
  • Drug: Niosomes
    Niosomes
    Other Name: nano-vesicles
Study Arms  ICMJE
  • Experimental: Niosomal salbutamol sulphate inhalers
    Niosomes
    Intervention: Drug: Niosomes
  • Placebo Comparator: salbutamol sulphate inhalers
    control testing
    Intervention: Drug: Salbutamol Sulphate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2017)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 5, 2017
Actual Primary Completion Date February 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Chronic disease
  • Smoking
  • Hospitalization
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03059017
Other Study ID Numbers  ICMJE SSMDI-2017-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Share of the results by Publication
Responsible Party Mona Gamal Mohamed Afifi Arafa, British University In Egypt
Study Sponsor  ICMJE British University In Egypt
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account British University In Egypt
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP