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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03302065
Other study ID # CSP-07-000030
Secondary ID
Status Completed
Phase Phase 1
First received October 2, 2017
Last updated October 2, 2017
Start date May 2016
Est. completion date January 2017

Study information

Verified date October 2017
Source 3M
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.


Description:

Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products and two reference inhalation products according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 48 hours post-dose.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date January 2017
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

- 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tiotropium


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
3M

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax maximum plasma concentration 48 hours
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