Bioequivalence Study of Tiotropium Bromide Inhalation Powder

PHASE3CompletedINTERVENTIONAL
Enrollment

306

Participants

Timeline

Start Date

March 24, 2022

Primary Completion Date

November 29, 2022

Study Completion Date

November 29, 2022

Conditions
COPD
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

Trial Locations (17)

6917

Phargentis SA (Central Contact), Barbengo

29340

Investigational Site 204, Gaffney

29379

Investigational Site 205, Union

29621

Investigational Site 203, Anderson

190001

Investigational Site 118, Jammu

380005

Investigational Site 108, Sābarmatī

380006

Investigational Site 119, Ahmedabad

382345

Investigational Site 101, Ahmedabad

382421

Investigational Site 120, Gandhinagar

390012

Investigational Site 102, Vadodara

390022

Investigational Site 107, Vadodara

395006

Investigational Site 114, Surat

411038

Investigational Site 111, Pune

422002

Investigational Site 121, Nashik

422101

Investigational Site 112, Nashik

440009

Investigational Site 106, Nagpur

440015

Investigational Site 105, Nagpur

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Phargentis SA

INDUSTRY