Pharmacokinetics and Safety of WAL2014 (Talsaclidine) Administered Orally to Healthy Adult Male Volunteers

NCT ID: NCT02264080

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-03-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

WAL2014

Group Type: EXPERIMENTAL

WAL2014

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

WAL2014

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Talsaclidine

Eligibility Criteria

Inclusion 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

Exclusion Criteria

1. Those who have a history of allergic reaction or hypersensitivity to drugs

2. Those who have received any kind of drug(s) within one week prior to the administration of the investigational product.

3. Those who have ingested alcoholic drink within two days before the administration of the investigational product

4. Those who have been admitted to a hospital, undergone surgery or donated blood within 3 months before the administration of the investigational product

5. 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

6. Those who participated in Phase I single dose study of the investigational product

7. Those who have a history of liver or renal disease

8. Those who are judged as ineligible for the clinical study by the investigator

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

506.112

Identifier Type: -

Identifier Source: org_study_id