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NCT06290102 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old

A Phase 1 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
10
Study locations

NCT06290102 is a Phase 1 study of Asthma that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 30 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The trial reports 10 study locations across 7 states.

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The verdict

NCT06290102, a Phase 1 study of Asthma, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
10
Study locations

Study Summary

The primary objectives of this study are: * To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module \[Fp/ABS eMDPI\]) in participants with asthma * To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI) * To compare the PK profiles of ABS between the 2 different strengths of TEV-56248 The secondary objective is: • To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI

Conditions Studied

Asthma

Interventions

  • DRUG TEV-56248
  • DRUG Fp MDPI

Study Locations (10)

Florida

  • Teva Investigational Site 12007 - Miami
  • Teva Investigational Site 12005 - Miami
  • Teva Investigational Site 12002 - Miami

Texas

  • Teva Investigational Site 12001 - Boerne
  • Teva Investigational Site 12009 - San Antonio

Alabama

  • Teva Investigational Site 12010 - Mobile

California

  • Teva Investigational Site 12003 - Long Beach

Louisiana

  • Teva Investigational Site 12008 - Lafayette

Missouri

  • Teva Investigational Site 12011 - Columbia

Oklahoma

  • Teva Investigational Site 12012 - Oklahoma City

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2024-05-16
Est. Completion 2024-10-07
Phase Phase 1

Sponsor

Teva Branded Pharmaceutical Products R&D

167 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06290102

The ClinicalTrials.gov registry entry for NCT06290102 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which TEV-56248 is the first listed.

NCT06290102 reports 10 study locations spanning 7 distinct geographic areas - top geographies include Florida, Texas, Alabama.

Frequently Asked Questions

What is clinical trial NCT06290102 about?

NCT06290102 is a clinical study titled "Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old". The primary objectives of this study are: * To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module \[Fp/ABS eMDPI\]) in participants wi...

What is the current status of trial NCT06290102?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-05-16. Estimated completion is 2024-10-07.

What conditions does trial NCT06290102 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT06290102?

The interventions under investigation include: TEV-56248 (DRUG), Fp MDPI (DRUG).

Who is sponsoring clinical trial NCT06290102?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06290102 being conducted?

This trial has 10 study locations across Alabama, California, Florida, Louisiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.