Clinical trial NCT03059017: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Effect
Pulmonary Disease
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 20
Sex: MALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Volunteers will be divided into two groups; each group contained 10 volunteers who will receive one formula of the selected formulae.
Primary purpose: TREATMENT

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 Three milliliters of blood will be withdrawn at 0, 0.5, 1, 2, 3, 4, 5 and 6 h after administration.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

Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Chronic disease
* Smoking
* Hospitalization

Primary outcomes:
measure: The maximum plasma concentration (Cmax)
timeFrame: Twenty Four Hours
Secondary outcomes:
measure: The time required to reach maximum plasma (Tmax)
timeFrame: Twenty Four Hours
Other outcomes:
measure: The area under plasma concentration time curve (AUC)
timeFrame: Twenty Four Hours
Locations:
Study officials:
References:
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.
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.