Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
NCT03073057 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2017-03-08
Summary
The purpose of this study is to compare Budesonide/formoterol Easyhaler test products with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
Conditions
Interventions
- DRUG
-
Budesonide/formoterol
2 inhalations as a single dose
- OTHER
-
Charcoal
- DRUG
-
Symbicort Turbuhaler
2 inhalations as a single dose
Sponsors & Collaborators
-
Orion Corporation, Orion Pharma
lead INDUSTRY
Principal Investigators
-
Iissa Kivisto · Orion Corporation, Orion Pharma
-
Leena Mattila, MD · Orion Pharma, Clinical Pharmacology Unit, Espoo, Finland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2016-03-31
- Completion
- 2016-03-31
Countries
- Finland
Study Locations
More Related Trials
-
Efficacy and Tolerability of Beclomethasone Dipropionate 100 µg + Formoterol 6 µg pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler®. (Symbicort®)
NCT00413387 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations
NCT00272753 ·Status: COMPLETED ·Phase: PHASE4
-
Titratable Dosing in Moderate to Severe Asthmatics
NCT00651768 ·Status: COMPLETED ·Phase: PHASE3
-
New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day
NCT01360021 ·Status: COMPLETED ·Phase: PHASE3
-
Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler
NCT00658255 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus
NCT02162485 ·Status: COMPLETED ·Phase: PHASE1
-
Safety & Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma
NCT00255255 ·Status: COMPLETED ·Phase: PHASE3
-
An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma
NCT00419757 ·Status: COMPLETED ·Phase: PHASE3
-
A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy
NCT01136655 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma
NCT01676987 ·Status: COMPLETED ·Phase: PHASE3
-
Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy
NCT00319306 ·Status: COMPLETED ·Phase: PHASE3
-
BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient
NCT05322707 ·Status: COMPLETED ·Phase: PHASE3
-
Assessment of the Efficacy and Safety of FlutiForm® pMDI 125/5 µg (2 Puffs Bid) Versus Symbicort® Turbohaler® 200/6 µg (2 Puffs Bid) in Adolescent and Adult Subjects With Moderate to Severe Persistent, Reversible Asthma
NCT01099722 ·Status: COMPLETED ·Phase: PHASE3
-
Symbicort Rapihaler Therapeutic Equivalence Study
NCT00536731 ·Status: COMPLETED ·Phase: PHASE3
-
Randomized, Placebo-controlled, Multi-dose, Study Comparing Budesonide/Formoterol to Symbicort® in Asthmatic Patients
NCT03015259 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
NCT02224157 ·Status: COMPLETED ·Phase: PHASE3
-
Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults
NCT00385593 ·Status: TERMINATED ·Phase: PHASE3
-
Prevention of Asthma Relapse After Discharge From Emergency
NCT00326053 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Symbicort on GR Localisation in Asthma
NCT00159263 ·Status: COMPLETED ·Phase: NA
-
SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults
NCT00238784 ·Status: COMPLETED ·Phase: PHASE3
-
Symbicort Single Inhaler Therapy for Asthma in a General Practice Setting
NCT00235911 ·Status: COMPLETED ·Phase: PHASE3
-
A Two-week Study Assessing the Onset of Effect Questionnaire (OEQ) Administered Daily Versus Weekly in Adult Subjects
NCT00449527 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mg
NCT00242775 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Safety and Efficacy of Symbicort® pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma
NCT00536913 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients
NCT00837967 ·Status: COMPLETED ·Phase: PHASE3