Status:
COMPLETED
Pharmacodynamic/Pharmacokinetic Interactions Between Oral Roflumilast and Inhaled Formoterol
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This Phase I, open, randomized controlled, multiple-dose, parallel-group study investigated the potential pharmacodynamic and pharmacokinetic interactions between multiple doses of oral roflumilast an...
Eligibility Criteria
Inclusion
- Age between 18 and 45 years
- Normal body weight as indicated by a Body Mass Index (BMI) between 18 and 30 kg/m2 and a body weight \> 50 kg
- Assessed as healthy, based on a screening examination including medical history, physical examination, BP, PuR, ECG, and clinical laboratory results
- Caucasian
Exclusion
- Suspected lack of compliance
- Participant in any other study or donation of blood during the last 30 d before start of this study (last day of intake of medication - first day of medication in the following study)
- Any active disease, acute or chronic (also psychiatric diseases)
- Any signs or present history of cardiac diseases (e.g. QTc interval acc. to Bazett ≥ 430 ms, PQ ≥ 220 ms), in particular tachycardiac arrhythmia, third-degree AV-block, idiopathic-subvalvular aortic stenosis or hypertrophic-obstructive cardiomyopathia
- Proneness to symptomatic orthostatic dysregulation, fainting or "blackouts" (medical history), or to orthostatic hypotension defined by SBP \< 90 mm Hg (standing blood pressure, 30 s after raising up from a supine position)
- Gastrointestinal surgery except from appendectomy and herniotomy
- HIV or hepatitis screening positive or not performed (in case of a positive HIV test, the subject had to be informed by a physician in personal communication
- Drug screening positive or not performed
- Excessive xanthine consumption (more than 5 cups of coffee or equivalent per day)
- Non-compliance for measurements of impedance cardiography (feasibility was proven and documented at the screening visit by one test procedure)
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00940329
Start Date
April 1 2004
End Date
December 1 2004
Last Update
December 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nycomed
Konstanz, Germany, 78467