Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler

NCT03400241 | Completed Phase 1

• 1 other identifier: 3122002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Peak plasma concentration (Cmax) of tiotropium

  between 0-72 hours 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

• 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

Secondary Outcomes (1)

• Time to reach peak concentration in plasma (tmax) of tiotropium

  between 0-72 hours after dosing

Other Outcomes (1)

• Adverse events

  throughout the study, an average of 10 weeks

Study Arms (4)

Tiotropium Easyhaler Product A

EXPERIMENTAL

tiotropium bromide monohydrate 2 inhalations as a single dose

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler Product B

EXPERIMENTAL

tiotropium bromide monohydrate 2 inhalations as a single dose

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler Product C

EXPERIMENTAL

tiotropium bromide monohydrate 2 inhalations as a single dose

Drug: Tiotropium Bromide Monohydrate

Spiriva HandiHaler

ACTIVE COMPARATOR

tiotropium bromide monohydrate 2 Spiriva capsules inhaled via HandiHaler

Drug: Tiotropium Bromide Monohydrate

Interventions

Tiotropium Bromide Monohydrate DRUG

Tiotropium Easyhaler 10 mcg/dose Product A

Tiotropium Easyhaler Product A

Eligibility Criteria

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

You may qualify if:

• Healthy male and female subjects
• years old
• Body mass index \>19 and \<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 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

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Clinical Pharmacology Unit

Espoo, Finland

Location

Study Officials

• Ulla Sairanen, MSc

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: February 19, 2018
• Primary Completion: April 18, 2018
• Study Completion: April 18, 2018
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

FI (1)