In Vivo Investigation of Novel Nano-vesicles of Salbutamol Sulphate

NCT03059017 | Completed Phase 1 FDA Drug

• 1 other identifier: SSMDI-2017-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Drug Effect; Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The time required to reach maximum plasma (Tmax)

  Twenty Four Hours

Other Outcomes (1)

• The area under plasma concentration time curve (AUC)

  Twenty Four Hours

Study Arms (2)

Niosomal salbutamol sulphate inhalers

EXPERIMENTAL

Niosomes

Drug: Niosomes

salbutamol sulphate inhalers

PLACEBO COMPARATOR

control testing

Drug: Salbutamol Sulphate

Interventions

Salbutamol Sulphate DRUG

salbutamol sulphate packaged as aerosol

salbutamol sulphate inhalers

Niosomes DRUG

Niosomes

Also known as: nano-vesicles

Niosomal salbutamol sulphate inhalers

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy

You may not qualify if:

• Chronic disease
• Smoking
• Hospitalization

Sponsors & Collaborators

• British University In Egypt: lead

Related Publications (2)

• 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.

  PMID: 12270249 BACKGROUND

• 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.

  PMID: 16009588 BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Interventions

Albuterol; Liposomes

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Volunteers will be divided into two groups; each group contained 10 volunteers who will receive one formula of the selected formulae.

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 23, 2017
• Study Start: February 5, 2017
• Primary Completion: February 5, 2017
• Study Completion: February 5, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share