Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler
- Registration Number
- NCT03400241
- Lead Sponsor
- Orion Corporation, Orion Pharma
- Brief Summary
Absorption of inhaled tiotropium is compared between three Tiotropium Easyhaler products and Spiriva capsules inhaled via HandiHaler. All subjects will receive all products as a single dose.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Healthy male and female subjects
- 18-60 years old
- Body mass index >19 and <30 kg/m2
- Weight at least 50 kg
- Written informed consent obtained
Exclusion Criteria
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
- Any condition requiring regular concomitant treatment.
- Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject.
- Known hypersensitivity to tiotropium bromide, atropine or its derivatives, or lactose.
- Pregnant or lactating females and females of childbearing potential not using proper contraception.
- Blood donation, loss of a significant amount of blood or administration of another investigational medicinal product within 90 days before the first study treatment administration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Tiotropium Easyhaler Product B Tiotropium Bromide Monohydrate tiotropium bromide monohydrate 2 inhalations as a single dose Tiotropium Easyhaler Product C Tiotropium Bromide Monohydrate tiotropium bromide monohydrate 2 inhalations as a single dose Spiriva HandiHaler Tiotropium Bromide Monohydrate tiotropium bromide monohydrate 2 Spiriva capsules inhaled via HandiHaler Tiotropium Easyhaler Product A Tiotropium Bromide Monohydrate tiotropium bromide monohydrate 2 inhalations as a single dose
- Primary Outcome Measures
Name Time Method Peak plasma concentration (Cmax) of tiotropium between 0-72 hours after dosing Truncated area under the concentration-time curve (AUC) of tiotropium from time zero to 30 min after study treatment administration 0-30 minutes after dosing Area under the concentration-time curve (AUC) of tiotropium from time zero to 72 h after the study treatment administration 0-72 hours after dosing
- Secondary Outcome Measures
Name Time Method Time to reach peak concentration in plasma (tmax) of tiotropium between 0-72 hours after dosing
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does Tiotropium Easyhaler's formulation affect muscarinic receptor occupancy and systemic exposure compared to Spiriva Handihaler in healthy subjects?
What are the comparative pharmacokinetic profiles of Tiotropium via Easyhaler and Handihaler in terms of Cmax and AUC in Phase 1 trials?
Which biomarkers correlate with Tiotropium systemic absorption from different inhaler devices in respiratory disease patients?
What adverse events are reported with Tiotropium Easyhaler versus Handihaler in Phase 1 studies, and how are they managed?
How does Orion's Tiotropium Easyhaler compare to other LAMAs like Glycopyrronium in pharmacokinetics and COPD therapeutic efficacy?
Trial Locations
- Locations (1)
Clinical Pharmacology Unit
🇫🇮Espoo, Finland
Clinical Pharmacology Unit🇫🇮Espoo, Finland