Status:
COMPLETED
Two-period 21 Day Cross-over Study to Compare the Pharmacokinetics of Tiotropium From Two Inhalers
Lead Sponsor:
Kindeva Drug Delivery
Collaborating Sponsors:
Simbec Research
3M
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the absorption of a test inhalation product with the reference product in healthy volunteers.
Detailed Description
Healthy subjects will be enrolled and will receive doses of a test inhalation product and a reference inhalation product for 28 days according to a crossover design. Plasma tiotropium levels will be m...
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
- 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
Key Trial Info
Start Date :
July 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03246581
Start Date
July 13 2017
End Date
May 3 2018
Last Update
December 4 2025
Active Locations (1)
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1
3M Health Care
Loughborough, United Kingdom