Healthy
Conditions
Brief summary
To assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a single dose to healthy adult male volunteers in double blind manner.
Interventions
DRUGTalsaclidine
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 4. Those who have received screening examinations listed in protocol 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 24 hours after drug administration |
| Time to reach maximum plasma concentration (tmax) | up to 24 hours after drug administration |
| Area under the plasma concentration-time curve (AUC) | up to 24 hours after drug administration |
| Distribution volume | up to 24 hours after drug administration |
| Total clearance | up to 24 hours after drug administration |
| Mean residence time (MRT) | up to 24 hours after drug administration |
| Urinary excretion rate | up to 24 hours after drug administration |
| Number of subjects with adverse events | up to 8 days after administration |
Outcome results
None listed