At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 16 enrolled

Drug / intervention

Budesonide Inhalation Suspension +3 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00627679

NCT00627679Phase 1Completed

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A Randomized, Double Blind, Active Controlled, Single Dose, 4 Arm, 4 Period Crossover, Phase 1 Study Investigating the Tolerability and Pharmacokinetics of MAP0010

Allergan·interventional·Posted Mar 3, 2008·Updated Jan 9, 2014

In Brief

A Phase 1 clinical trial evaluating Budesonide Inhalation Suspension, MAP0010 low dose, and 2 other interventions for Asthma. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAsthma

CountriesAustralia

CollaboratorsMAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan, Q-Pharm Pty Limited

Timeline

Phase 1CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartDec 2005

Primary CompletionDec 2005

Study CompletionMay 2006

First PostedMar 2008

TodayJul 2026

First PostedMar 3, 2008

Enrollment StartDec 1, 2005

Primary CompletionDec 1, 2005

Study CompletionMay 1, 2006

TodayJul 2, 2026

Enrollment to primary: 0 daysPosted 18.3 years ago

Interventions

Budesonide Inhalation Suspensiondrug

Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.

MAP0010 low dosedrug

Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.

MAP0010 intermediate dosedrug

Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.

MAP0010 high dosedrug

Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.