Tiotropium Steady-state Pharmacokinetics in Healthy Volunteers
This study aims to evaluate the peak plasma concentration of Tiotropium in healthy volunteers to understand its steady-state pharmacokinetics.
Tiotropium
Pathologic Processes+2
+ Respiration Disorders
+ Respiratory Tract Diseases
Basic Science Study
Summary
Study start date: July 13, 2017
Actual date on which the first participant was enrolled.This study is focused on understanding how a new test inhaler product delivers the medication tiotropium in the body compared to an existing inhaler product, Spiriva Respimat. The study involves healthy male and female volunteers and is designed to observe how the body processes the medication over time. By comparing the two inhalers, researchers aim to gather information that could lead to improved delivery methods for respiratory medications, potentially benefiting patients who need better treatment options for managing their breathing conditions. Participants in the study will use both the test inhaler and the reference inhaler in a sequence over 28 days. They will switch between the two inhalers during the study period, which is called a crossover design. Blood samples will be taken from participants before and after they use the inhalers to measure the levels of tiotropium in the bloodstream, focusing on the peak concentration after dosing. This approach helps scientists determine how effectively each inhaler delivers the medication and how long it stays active in the body. The study carefully monitors this to ensure accurate and safe comparisons.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location