Status:
COMPLETED
Pharmacokinetics and Safety of WAL2014 (Talsaclidine) Administered Orally to Healthy Adult Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
20-30 years
Phase:
PHASE1
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.
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 \[standard body weight = (height - 100) x 0.9\]
- 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.
- 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 week 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 participated in Phase I single dose study 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 :
March 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02264080
Start Date
March 1 1999
Last Update
October 15 2014
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