Comparative assessment of the absorption of a generic formulation of Inhaled Insulin against the innovators Humalog KwikPen for injection and the AFREZZA Inhalation Powder Cartridge conducted under fasting conditions in healthy male and female volunteers
- Conditions
- Pharmacokinetic and pharmacodynamic study conducted in healthy volunteers comparing three formulations of Insulin with no health condition or problem studied. Insulin is a medicine that is used to lower blood glucose.Pharmacokinetic and pharmacodynamic study conducted in healthy volunteers comparing three formulations of Insulin with no health condition or problem studied.Insulin is a medicine that is used to lower blood glucose.Other - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12615001100583
- Lead Sponsor
- Zenith Technology Corp Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 21
Healthy male and non-pregnant females
Aged between 18 and 55
Non-smoker
BMI between 18 and 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure, spirometry, oximetry, chest x-ray and laboratory tests
Able to provide written informed consent
Any history of recent recurrent attacks of bronchitis, COPD, emphysema, bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind
Sensitivity to insulin or any other similar class of medicines, or the excipients of insulin
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or are breastfeeding
Smoker (anyone who has smoked in the last 6 months)
History of alcohol or drug abuse or dependency
Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study.
Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the pharmacokinetic and pharmacodynamic parameters of insulin (as summarised by Cmax and AUC) for the three formulation. All serum samples will be assayed for insulin using one fully validated ELISA method. Validation will be conducted to comply with EU and FDA guidelines.[-30, -20, -10, 0, 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 240, 360, 420 and 480 minutes after dosing]
- Secondary Outcome Measures
Name Time Method Time to maximum peak concentration (Tmax) will be determined by serum sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points.[-30, -20, -10, 0, 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 240, 360, 420 and 480 minutes after dosing]