CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 91 enrolled
Drug / intervention
Z7200 without oral activated charcoal +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/NCT02631941
NCT02631941Phase 1Completed
CompareCT.gov

An Open-Label, Randomized, Five-Period Cross-over, Single-dose Study to Compare Pharmacokinetics Profiles of Z7200 Medium Strength and Symbicort Turbohaler, With and Without Charcoal Blockade in Healthy Volunteers.

Zambon SpA·interventional·Posted Dec 16, 2015·Updated Feb 23, 2022

In Brief

A Phase 1 clinical trial evaluating Z7200 without oral activated charcoal, Symbicort Turbohaler without oral activated charcoal, and 2 other interventions for Asthma. Completed, enrolled 91 participants across 1 site.

Detailed Summary

Brief Summary: The primary objective was: * to assess the bioequivalence of a single dose (two inhalations) of the test product compared to the reference product, with and without charcoal blockade. The secondary objectives were: * to assess the pharmacokinetic profile of budesonide and formoterol in plasma after a single dose (two inhalations) of the test product and the reference product, with and without charcoal blockade. * to assess the safety and tolerability of the test product and the reference product, with and without charcoal blockade.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 16, 2015
Enrollment StartJan 1, 2016
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.5 years ago

Interventions

Z7200 without oral activated charcoaldrug

160 ug budesonide and 4.5 ug formoterol fumarate dihydrate, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).

Symbicort Turbohaler without oral activated charcoaldrug

320 ug budesonide and 9 ug formoterol fumarate dihydrate, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2 denote Symbicort without oral activated charcoal administered in two different periods).

Z7200 with oral activated charcoaldrug

160 ug budesonide and 4.5 ug formoterol fumarate dihydrate, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).

Symbicort Turbohaler with oral activated charcoaldrug

320 ug budesonide and 9 ug formoterol fumarate dihydrate, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation from a Symbicort Turbohaler, with charcoal blockade (Treatment D).