In Vivo Investigation of Novel Nano-vesicles of Salbutamol Sulphate

Phase 1

Completed

• Conditions: Pulmonary Disease; Drug Effect
• Interventions: Drug: Niosomes; Drug: Salbutamol Sulphate

• Registration Number: NCT03059017
• Lead Sponsor: British University In Egypt

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 Three milliliters of blood will be withdrawn at 0, 0.5, 1, 2, 3, 4, 5 and 6 h after administration.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

• Status Verified: 2017-02
• Study Start: 2017-02-05
• Primary Completion: 2017-02-05
• Study Completion: 2017-02-05
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-16
• Last Update Submitted: 2017-02-16
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Healthy

Exclusion Criteria

• Chronic disease
• Smoking
• Hospitalization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Niosomal salbutamol sulphate inhalers	Niosomes	Niosomes
salbutamol sulphate inhalers	Salbutamol Sulphate	control testing

Primary Outcome Measures

Name	Time	Method
The maximum plasma concentration (Cmax)	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.

Secondary Outcome Measures

Name	Time	Method
The time required to reach maximum plasma (Tmax)	Twenty Four Hours	Time taken for Salbutamol Sulphate to reach its maximum concentration in human blood \& will be calculated using validated using Excel software