Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®

NCT04850144 | Completed Phase 1

• 1 other identifier: 3122005
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of tiotropium is compared between one Easyhaler product variant administered with and without charcoal.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Peak tiotropium concentration in plasma (Cmax)

  between 0-72 hours after dosing

• Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes)

  0-30 minutes after dosing

• Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)

  0-72 hours after dosing

Secondary Outcomes (1)

• Time to reach peak concentration in plasma (tmax)

  between 0-72 hours after dosing

Other Outcomes (1)

• Adverse events

  througout the study, an average 9 weeks

Study Arms (7)

Tiotropium Easyhaler Product variant D

EXPERIMENTAL

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler Product variant E

EXPERIMENTAL

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler Product variant F

EXPERIMENTAL

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler Product variant G

EXPERIMENTAL

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler Product variant H

EXPERIMENTAL

Drug: Tiotropium Bromide Monohydrate

Spiriva HandiHaler

ACTIVE COMPARATOR

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler Product variant F administered with oral activated charcoal

EXPERIMENTAL

Drug: Tiotropium Bromide Monohydrate; Drug: Tiotropium Easyhaler with oral activated charcoal

Interventions

Tiotropium Bromide Monohydrate DRUG

Tiotropium Easyhaler 10 µg/dose Product variant D

Tiotropium Easyhaler Product variant D

Tiotropium Easyhaler with oral activated charcoal DRUG

The charcoal suspension will be administered orally with Tiotropium Easyhaler 10 µg/dose Product variant F

Tiotropium Easyhaler Product variant F administered with oral activated charcoal

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females
• years of age
• Body mass index 19-30 kg/m2
• Weight at least 50 kg
• Written informed consent obtained

You may not qualify if:

• 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 could interfere with the interpretation of study results or cause 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 contraception of acceptable effectiveness
• Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Clinical Pharmacology Unit, Orion Corporation

Espoo, Finland

Location

MeSH Terms

Interventions

Charcoal

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Study Officials

• Orion Corporation Clinical Study Director

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Bioanalytical laboratory will be blinded with regard to the sequence of the product administration.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a 2-part 4-period crossover study where the study subjects participate either in part 1 (20 subjects) or in part 2 (20 subjects). Parts can run in sequence or parallel. All study subjects receive single dose of Tiotropium Easyhaler on 3 periods and Spiriva HandiHaler on 1 period.

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 20, 2021
• Study Start: April 26, 2021
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)