Protocol With Amendments 1 and 2: Phase I Randomised, Two-period 21 Day Crossover Study in Healthy Male and Female Volunteers to Compare the Steadystate Pharmacokinetics of Tiotropium Delivered From a Test pMDI Product With Spiriva Respimat
| Registry | NCT03246581 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: none, basic science |
| Enrollment | 40 (Actual) |
| Sponsor | Kindeva Drug Delivery (Industry); collaborators: Simbec Research, 3M |
| Conditions | Healthy |
| Interventions | Tiotropium (Drug) |
| Dates | start 2017-07-13, primary completion 2018-01-21, completion 2018-05-03, first posted 2017-08-11, last updated 2025-12-04 |
| Locations | 1 site in United Kingdom |
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All trials for Healthy All trials of Tiotropium
The purpose of this study is to compare the absorption of a test inhalation product with the reference product in healthy volunteers.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Test Product | Experimental | Drug: Tiotropium | tiotropium pMDI 2 inhalations |
| Commercial Product | Active comparator | Drug: Tiotropium | tiotropium pMDI 2 inhalations |
Sex: All, ages: 18 Years to 55 Years, 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
| Facility | City | Country | Status |
|---|---|---|---|
| 3M Health Care | Loughborough | United Kingdom |