Healthy
Conditions
Brief summary
Study to assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a multiple dose to healthy adult male volunteers in double blind manner.
Interventions
DRUGWAL2014
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
20 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects for the study are healthy male adult volunteers who meet all the inclusion criteria listed below and do not fall into the
Exclusion criteria
. 1. Age: 20-30 years old 2. Body weight: 50-80 kg 3. Obesity index: within +/-20% of the standard body weight \[standard body weight = (height - 100) x 0.9\] 4. Those who have received screening examinations listed in Table 1 within one month prior to the start of the clinical study and have been judged as eligible by the investigator. Results of the simple test for gastric acidity are not used as the basis of the judgment. 5. Those who belong to volunteer members' association which has an office in Clinical Pharmacology Center, Ohsaki Clinic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum concentration of the analyte in plasma (Cmax) | up to day 14 |
| Time to reach maximum plasma concentration (tmax) | up to day 14 |
| Area under the plasma concentration-time curve (AUC) | up to day 14 |
| Urinary excretion rate | up to day 14 |
| Minimum plasma concentration (Cmin) | up to day 14 |
| Mean residence time (MRT) | up to day 14 |
| Terminal half-life (t1/2) | up to day 14 |
| Distribution volume | up to day 14 |
| Total clearance | up to day 14 |
| Number of subjects with adverse events | up to 22 days |
Outcome results
None listed