Overview
Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets
Status:
Completed
Completed
Trial end date:
2012-11-01
2012-11-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
This study should estimate the dose proportionality of BAY94-8862 IR tablets.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Bayer
Criteria
Inclusion Criteria:- Healthy male subject
- Age: 18 to 46 years (inclusive) at the first screening examination
- Ethnicity: White
- Body mass index (BMI): >= 18 and <= 29.9 kg / m²
Exclusion Criteria:
- Clinically relevant findings in the ECG (electrocardiogram) such as a second- or
third-degree AV block, prolongation of the QRS complex over 120 msec
- Systolic blood pressure below 100 or above 140 mmHg
- Diastolic blood pressure below 50 or above 90 mmHg
- Heart rate below 50 or above 95 beats/ min
- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus
antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
- Participation in another clinical study during the preceding 3 months (Last Treatment
from previous study to First Treatment of new study)