Status:
COMPLETED
Exploratory Study of Additional Use of Scopolamine Butylbromide, Glucagon or NPO-11 Following Single Dose of NPO-11 in Healthy Adult Men
Lead Sponsor:
Nihon Pharmaceutical Co., Ltd
Conditions:
Healthy
Eligibility:
MALE
35-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the additional administration of scopolamine butylbromide, glucagon or NPO-11 following a single intragastric dose of NPO-11 during ...
Eligibility Criteria
Inclusion
- Healthy adult male volunteers who meet all the following criteria will be enrolled in the study. Subjects have to provide written informed consent for voluntary participation in the study.
- Volunteers who are in good health as confirmed by the investigator or subinvestigator
- Volunteers (age from 35 to less than 65 years old at the time of consent)
Exclusion
- Volunteers who meet any of the following criteria will be excluded from the study.
- Volunteers with any clinically significant symptoms, physical findings or laboratory values at screening visit which are considered unsuitable for participation in the study in the investigator's or subinvestigator's opinion
- Volunteers with a history of surgery in the upper gastrointestinal tract
- Volunteers with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
- Volunteers with a history of shock or hypersensitivity to scopolamine butylbromide, glucagon, lidocaine hydrochloride or heparin sodium
- Volunteers who are contraindicated for administration of scopolamine butylbromide or glucagon in the investigator's or subinvestigator's opinion based on health interview
- Volunteers who have been exposed to NPO-11
- Volunteers who have received other investigational drugs within four months before consent or who are participating in other clinical studies
- Volunteers otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00740324
Start Date
August 1 2008
End Date
July 1 2009
Last Update
November 9 2010
Active Locations (1)
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1
Tokyo, Japan