Status:
COMPLETED
Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate
Lead Sponsor:
Kindeva Drug Delivery
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 pl...
Eligibility Criteria
Inclusion
- 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
- 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)
- Surgery scheduled during the study or within 3 weeks after last dose
- History of familial long QT syndrome or history of sudden death in family members aged \< 30 years
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT02232087
Start Date
July 1 2014
End Date
December 1 2014
Last Update
June 15 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Quotient Clinical Ltd
Ruddington, Nottingham, United Kingdom, NG11 6JS