Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) in Healthy Adult Males

Launched by BOEHRINGER INGELHEIM · Aug 15, 2014

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Age between 20 and 35 years
• • Weight between 50 and 80 kg
• • Obesity level within the range of +/- 20% of the standard weight according to the Body Mass Index (BMI) method
• • Judged as eligible as a study object following the screening test by the investigator
• • Volunteers to participate in the study, who are capable of giving written informed consent
• Exclusion Criteria:
• • Known hypersensitivity to drugs
• • History of drug or alcohol abuse
• • Received other investigational drug within 4 months of the trial drug administration
• • Had \> 400 mL of whole blood drawn within 3 months of the trial drug administration
• • Had \> 400 mL of blood components drawn within 1 month of the trial drug administration
• • Used any drug within 10 days of the trial drug administration
• • Engaged in strenuous exercise within 5 days of the trial drug administration
• • Consumed alcohol within 3 days of the trial drug administration
• • Judged as ineligible for the study participation by the investigator for a reason other than above