Status:
COMPLETED
Pharmacokinetics and Safety of WAL2014 (Talsaclidine) in Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
20-30 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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.
- Age: 20-30 years old
- Body weight: 50-80 kg
- Obesity index: within +/-20% of the standard body weight
- 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.
- Those who belong to volunteer members' association which has an office in Clinical Pharmacology Center, Ohsaki Clinic
Exclusion
- Those who have a history of allergic reaction or hypersensitivity to drugs
- Those who have received any kind of drug(s) within one month prior to the administration of the investigational product
- Those who have ingested alcoholic drink within two days before the administration of the investigational product
- Those who have been admitted to a hospital, undergone surgery or donated blood within 3 months before the administration of the investigational product
- Those who have participated in a phase I clinical study of a drug which contains a new active ingredient or a similar study within 4 months before the administration of the investigational product
- Those who have a history of liver or renal disease
- Those who are judged as ineligible for the clinical study by the investigator.
Key Trial Info
Start Date :
July 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02264067
Start Date
July 1 1998
Last Update
October 15 2014
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