In Vivo Investigation of Novel Nano-vesicles of Salbutamol Sulphate
Primary Purpose
Drug Effect, Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Salbutamol Sulphate
Niosomes
Sponsored by
About this trial
This is an interventional treatment trial for Drug Effect
Eligibility Criteria
Inclusion Criteria:
- Healthy
Exclusion Criteria:
- Chronic disease
- Smoking
- Hospitalization
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Niosomal salbutamol sulphate inhalers
salbutamol sulphate inhalers
Arm Description
Niosomes
control testing
Outcomes
Primary Outcome Measures
The maximum plasma concentration (Cmax)
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.
Secondary Outcome Measures
The time required to reach maximum plasma (Tmax)
Time taken for Salbutamol Sulphate to reach its maximum concentration in human blood & will be calculated using validated using Excel software
Full Information
NCT ID
NCT03059017
First Posted
February 15, 2017
Last Updated
February 16, 2017
Sponsor
British University In Egypt
1. Study Identification
Unique Protocol Identification Number
NCT03059017
Brief Title
In Vivo Investigation of Novel Nano-vesicles of Salbutamol Sulphate
Official Title
Novel Nano-vesicles of Salbutamol Sulphate in Metered Dose Inhalers: Formulation, Characterization, In Vitro and In Vivo Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 5, 2017 (Actual)
Primary Completion Date
February 5, 2017 (Actual)
Study Completion Date
February 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British University In Egypt
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Effect, Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Niosomal salbutamol sulphate inhalers
Arm Type
Experimental
Arm Description
Niosomes
Arm Title
salbutamol sulphate inhalers
Arm Type
Placebo Comparator
Arm Description
control testing
Intervention Type
Drug
Intervention Name(s)
Salbutamol Sulphate
Intervention Description
salbutamol sulphate packaged as aerosol
Intervention Type
Drug
Intervention Name(s)
Niosomes
Other Intervention Name(s)
nano-vesicles
Intervention Description
Niosomes
Primary Outcome Measure Information:
Title
The maximum plasma concentration (Cmax)
Description
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.
Time Frame
Twenty Four Hours
Secondary Outcome Measure Information:
Title
The time required to reach maximum plasma (Tmax)
Description
Time taken for Salbutamol Sulphate to reach its maximum concentration in human blood & will be calculated using validated using Excel software
Time Frame
Twenty Four Hours
Other Pre-specified Outcome Measures:
Title
The area under plasma concentration time curve (AUC)
Description
The integral in a plot of concentration of Salbutamol Sulphate in blood plasma against time.
Time Frame
Twenty Four Hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy
Exclusion Criteria:
Chronic disease
Smoking
Hospitalization
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Share of the results by Publication
Citations:
PubMed Identifier
12270249
Citation
Ball DJ, Hirst PH, Newman SP, Sonet B, Streel B, Vanderbist F. Deposition and pharmacokinetics of budesonide from the Miat Monodose inhaler, a simple dry powder device. Int J Pharm. 2002 Oct 1;245(1-2):123-32. doi: 10.1016/s0378-5173(02)00338-1.
Results Reference
background
PubMed Identifier
16009588
Citation
Balanag VM, Yunus F, Yang PC, Jorup C. Efficacy and safety of budesonide/formoterol compared with salbutamol in the treatment of acute asthma. Pulm Pharmacol Ther. 2006;19(2):139-47. doi: 10.1016/j.pupt.2005.04.009. Epub 2005 Jul 11.
Results Reference
background
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In Vivo Investigation of Novel Nano-vesicles of Salbutamol Sulphate
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