MedTrace Logo

Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT05986591 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2024-01-31

No results posted yet for this study

Summary

Bioequivalence Study of Tiotropium Bromide Inhalation Powder 18 μg

Conditions

Interventions

COMBINATION_PRODUCT

Test Product - Tiotropium Bromide Inhalation Powder 18 mcg

Test Product

COMBINATION_PRODUCT

Spiriva Handihaler (Tiotropium Bromide) 18 mcg

RLD

COMBINATION_PRODUCT

Placebo

Placebo Product

Sponsors & Collaborators

  • Exeltis

    collaborator INDUSTRY

  • Laboratorios Liconsa

    collaborator INDUSTRY

  • Xiromed LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-17
Primary Completion
2023-08-11
Completion
2023-08-14
FDA Drug
Yes

Countries

  • United States
  • India

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 NCT05986591 on ClinicalTrials.gov