In Vivo Investigation of Novel Nano-vesicles of Salbutamol Sulphate
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| ClinicalTrials.gov Identifier: NCT03059017 |
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Recruitment Status :
Completed
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Drug Effect Pulmonary Disease | Drug: Salbutamol Sulphate Drug: Niosomes | Phase 1 |
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 Three milliliters of blood will be withdrawn at 0, 0.5, 1, 2, 3, 4, 5 and 6 h after administration.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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| 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 |
| Official Title: | Novel Nano-vesicles of Salbutamol Sulphate in Metered Dose Inhalers: Formulation, Characterization, In Vitro and In Vivo Evaluation |
| Actual Study Start Date : | February 5, 2017 |
| Actual Primary Completion Date : | February 5, 2017 |
| Actual Study Completion Date : | February 5, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Niosomal salbutamol sulphate inhalers
Niosomes
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Drug: Niosomes
Niosomes
Other Name: nano-vesicles |
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Placebo Comparator: salbutamol sulphate inhalers
control testing
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Drug: Salbutamol Sulphate
salbutamol sulphate packaged as aerosol |
- 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.
- 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
- 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.
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| Ages Eligible for Study: | 30 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy
Exclusion Criteria:
- Chronic disease
- Smoking
- Hospitalization
Publications:
| Responsible Party: | Mona Gamal Mohamed Afifi Arafa, Lecturer, British University In Egypt |
| ClinicalTrials.gov Identifier: | NCT03059017 History of Changes |
| Other Study ID Numbers: |
SSMDI-2017-01 |
| First Posted: | February 23, 2017 Key Record Dates |
| Last Update Posted: | February 23, 2017 |
| Last Verified: | February 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Share of the results by Publication |
| 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 |
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Lung Diseases Blister Respiratory Tract Diseases Skin Diseases, Vesiculobullous Skin Diseases Pathological Conditions, Anatomical Albuterol Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Asthmatic Agents Respiratory System Agents Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |