To Assess the Bioequivalence of Brotizolam Tablets 250 Mcg vs. Lendormin Tablets 250 Mcg Administered to Healthy Adult Volunteers

Inclusion criteria

• Healthy volunteers, provision of signed written informed consent before enrolment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
• Healthy adult male, aged between 20 and 40 years old.
• Body Mass Index (BMI) between 18.5 and 25, inclusive, (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2]).
• Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
• No significant deviation from normal biochemistry examination.
• No significant deviation from normal haematology examination.
• No significant deviation from normal urinalysis examination.

Exclusion criteria

• History of drug or alcohol abuse within the past one year.
• Medical history of allergic asthma or sensitivity to analogous drug.
• Evidence of chronic or acute infectious diseases from 4 weeks before the study.
• Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
• Ongoing peptic ulcer and constipation.
• Planned vaccination during the time course of the study.
• Taking any clinical investigation drug from 3 months before the study.
• Use of any medication, including herb medicine or vitamins from 4 weeks before the study.
• Donation of greater than 250 ml of blood in the past 3 months prior to dosing or donation of 250 ml of blood in the past 2 months prior to dosing.
• A positive Hepatitis B surface antigen or positive Hepatitis C antibody result.
• A positive test for HIV(Human immunodeficiency virus) antibody.