In Vivo Investigation of Novel Nano-vesicles of Salbutamol Sulphate

Pulmonary Disease Clinical Trial

Official title:

Novel Nano-vesicles of Salbutamol Sulphate in Metered Dose Inhalers: Formulation, Characterization, In Vitro and In Vivo Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059017
• Other study ID #: SSMDI-2017-01
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2017
• Last updated: February 16, 2017
• Start date: February 5, 2017
• Est. completion date: February 5, 2017

Study information

• Verified date: February 2017
• Source: British University In Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Three milliliters of blood will be withdrawn at 0, 0.5, 1, 2, 3, 4, 5 and 6 h after administration.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 5, 2017
• Est. primary completion date: February 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy

Exclusion Criteria:

• Chronic disease

• Smoking

• Hospitalization

Related Conditions & MeSH terms

• Drug Effect
• Lung Diseases
• Pulmonary Disease

Intervention

Drug:
• Salbutamol Sulphate
salbutamol sulphate packaged as aerosol
• Niosomes
Niosomes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
British University In Egypt

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The area under plasma concentration time curve (AUC)	The integral in a plot of concentration of Salbutamol Sulphate in blood plasma against time.	Twenty Four Hours
Primary	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.	Twenty Four Hours
Secondary	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	Twenty Four Hours