Two-period 21 Day Cross-over Study to Compare the Pharmacokinetics of Tiotropium From Two Inhalers

Kindeva

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Tiotropium

Study type

Interventional

Funder types

Industry

Identifiers

NCT03246581

CSP-07-000040

Details and patient eligibility

About

The purpose of this study is to compare the absorption of a test inhalation product with the reference product in healthy volunteers.

Full 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 measured predose and over 24 hours postdose on days 1 and 28.

Enrollment

40 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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
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