Status:
UNKNOWN
Safety Study of Anti-Asthma Agent BMEC-1217B
Lead Sponsor:
Medigreen Biotechnology Corp.
Conditions:
Asthma
Eligibility:
All Genders
20-40 years
Phase:
PHASE1
Brief Summary
BMEC-1217B is an abbreviated version of an old Chinese formulation. The ratio of each component was adopted by the sponsor following the observation that BMEC-1217B prepared from this ratio resulted i...
Eligibility Criteria
Inclusion
- Nonsmoking healthy adults between 20 and 40 years old.
- Determined to be in good health based on medical history, clinical laboratory test values within normal range. Body weight within 20% of the ideal body weight \[(height - 80) x 0.7\].
- No recent history of drug or alcohol abuse within one year prior to study enrollment
- Signed informed consent form.
Exclusion
- Has any condition that interferes with the ability of the subject to comply with the requirements of the study.
- Has known allergy to the study drug.
- Has an acute illness or surgery within 28 days prior to study enrollment
- Has participated in other investigational trials within 28 days prior to study enrollment.
- Has taken prescription medication and/or over-the-counter medication\*4 and/or botanical medications within 28 days prior to study enrollment.
- Has alcohol and caffeine consumption within 24 hours prior to the administration of study drug.
- Has evidence of significant renal, cardiovascular, hepatic, hematopoetic, neurological, pulmonary or gastrointestinal pathology, or any other medical reason or disease that might interfere with the study objectives, as determined by the investigator.
- Has donation or receive of more than 450 mL of blood within 28 days prior to the study enrollment.
- Female subjects of child bearing potential who are pregnant, nursing, do not agree to practice effective birth control during the time period from 14 days before administration of study drug to 28 days after administration of study drug, or with irregular or abnormal menstruation.
- Clinically significant deviation from normal physical examination findings that, in the principal investigator's judgment, may interfere with the study evaluation or affect subject safety.
- Test positive for HIV, HBV or HCV
- Test results indicate liver function failure
- Has been diagnosed with Diabetes Mellitus
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00425971
Start Date
July 1 2008
Last Update
September 4 2008
Active Locations (1)
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1
Tri-Service General Hospital
Taipei, Taiwan, 114