Phase I Single Blind, Randomised, Cross-over Pharmacodynamic Dose Response Study in Healthy Volunteers of Two Pressurized Metered Dose Inhalers (pMDIs) That Deliver Salmeterol and Fluticasone Propionate
Overview
- Phase
- Phase 1
- Intervention
- fluticasone propionate
- Conditions
- Healthy
- Sponsor
- Kindeva Drug Delivery
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Relative Potency QTcB Interval
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to test the body's response to several doses of two different inhalation products in healthy volunteers.
Detailed Description
Healthy subjects will be enrolled and will receive 2, 6, and 12 inhalations from both the test and reference pMDI products according to a six-period cross-over design. Electrocardiograms (ECGs) and plasma potassium and glucose levels will be measured pre-dose and over 6 hours post-dose.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy Volunteer
- •Willing and able to give informed consent
- •Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
- •Male and female subjects aged 18 to 55 years (inclusive)
- •Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration
Exclusion Criteria
- •Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
- •Any presence or history of a clinically significant allergy including any adverse reaction to study drug
- •History of drug or alcohol abuse within the past 2 years
- •Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
- •Donation or loss of greater than 400 mL of blood within the previous 3 months
- •Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
- •Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
- •Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
- •If female, nursing, lactating or pregnant
- •Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
Arms & Interventions
test product C
salmeterol and fluticasone propionate, 12 puffs
Intervention: fluticasone propionate
test product A
salmeterol and fluticasone propionate, 2 puffs
Intervention: Salmeterol
test product A
salmeterol and fluticasone propionate, 2 puffs
Intervention: fluticasone propionate
reference product D
salmeterol and fluticasone propionate, 2 puffs
Intervention: Salmeterol
reference product D
salmeterol and fluticasone propionate, 2 puffs
Intervention: fluticasone propionate
test product B
salmeterol and fluticasone propionate, 6 puffs
Intervention: Salmeterol
test product B
salmeterol and fluticasone propionate, 6 puffs
Intervention: fluticasone propionate
reference product E
salmeterol and fluticasone propionate, 6 puffs
Intervention: Salmeterol
reference product E
salmeterol and fluticasone propionate, 6 puffs
Intervention: fluticasone propionate
test product C
salmeterol and fluticasone propionate, 12 puffs
Intervention: Salmeterol
reference product F
salmeterol and fluticasone propionate, 12 puffs
Intervention: Salmeterol
reference product F
salmeterol and fluticasone propionate, 12 puffs
Intervention: fluticasone propionate
Outcomes
Primary Outcomes
Relative Potency QTcB Interval
Time Frame: Baseline up to 6 hrs
Selection of steepest part of dose response curve for Relative Potency: 2 and 6 inhalation dose pairs. Slope of A and B line compared with slope of D and E to obtain relative potency value. Twelve inhalation dose not utilized as not on steepest part of curve.
Relative Potency Max Heart Rate
Time Frame: Baseline, up to 6 hrs
Selection of steepest part of dose response curve for Relative Potency: 6 and 12 inhalation dose pairs. Slope of B and C line compared with slope of E and F to obtain relative potency value. Two inhalation dose not utilized as not on steepest part of curve.
Secondary Outcomes
- Max Heart Rate(Baseline through 6 hours)
- Plasma Potassium Level(baseline through 6 hours)
- Max Plasma Glucose Level(baseline through 6 hours)
- Max QTcB(Baseline through 6 hours)