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Bioequivalence Study of Tiotropium Bromide Inhalation Powder

NCT05161156 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2023-04-10

No results posted yet for this study

Summary

This study is to characterize the pharmacodynamic characteristics and to assess the therapeutic bioequivalence after single dose of Tiotropium Bromide Inhalation Powder-test relative to Tiotropium Bromide Inhalation Powder-reference in Adult Patients with Chronic Obstructive Pulmonary Disease (COPD) as primary objective

Conditions

Interventions

COMBINATION_PRODUCT

Test Product (tiotropium bromide inhalation powder)

A single dose of test product

COMBINATION_PRODUCT

18 mcg of Spiriva (Reference Product)

A single dose of reference product (Spiriva)

COMBINATION_PRODUCT

Placebo

A single dose of placebo

Sponsors & Collaborators

  • Phargentis SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2022-11-29
Completion
2022-11-29
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • India
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05161156 on ClinicalTrials.gov