Comparative assessment of the absorption of a generic formulation of tiotropium test product 1 and tiotropium test product 2 against the innovator Spiriva HandiHaler conducted under fasting conditions in healthy male and female volunteers

Phase 1

Completed

• Conditions: Bioavailability study conducted in healthy volunteers comparing three formulations of tiotropium with no health condition or problem studied. Tiotropium is a long-acting, antimuscarinic agent, which is often referred to as an anticholinergic and is used to make breathing easier for people with Chronic Obstructive Pulmonary Disease (COPD).; Bioavailability study conducted in healthy volunteers comparing three formulations of tiotropium with no health condition or problem studied.; Tiotropium is a long-acting, antimuscarinic agent, which is often referred to as an anticholinergic and is used to make breathing easier for people with Chronic Obstructive Pulmonary Disease (COPD).; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12615000073505
• Lead Sponsor: Zenith Technology Corp Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Healthy male and non-pregnant females
Aged between 18 and 45
Non-smoker
BMI between 18.5 and 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure, spirometry, oximetry and laboratory tests
Able to provide written informed consent

Exclusion Criteria

Any history of recent recurrent attacks of bronchitis, COPD, asthma, migraine headaches
Concomitant drug therapy of any kind
Sensitivity to tiotropium or any other similar class of medicines, or the excipients of tiotropium
Who have a history of known allergy to milk protein or food allergy
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or are breastfeeding
Smoker (anyone who has smoked in the last 6 months)
History of alcohol or drug abuse or dependency
Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study.
Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk

Study & Design

• Study Type: Interventional
• Study Design: Not specified