Healthy
Conditions
Brief summary
The objective of the study was to assess the bioequivalence of Lendormin Tablets (Delpharm Reims) vs. Lendormin Tablets (Synmosa Biopharma Co. Ltd.) following oral administration
Interventions
DRUGLendormin tablet
Lendormin tablet 250mc is administrated and compared
DRUGBrotizolam tablet
Brotizolam tablet 250mc is administrated and compared
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Healthy adult male, aged between 20 and 40 years old. 3. Body Mass Index (BMI) between 18.5 and 25, inclusive, (BMI will be calculated as weight in kilogram \[kg\]/height in meters2 \[m2\]). 4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram. 5. No significant deviation from normal biochemistry examination. 6. No significant deviation from normal haematology examination. 7. No significant deviation from normal urinalysis examination.
Exclusion criteria
1. History of drug or alcohol abuse within the past one year. 2. Medical history of allergic asthma or sensitivity to analogous drug. 3. Evidence of chronic or acute infectious diseases from 4 weeks before the study. 4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology. 5. Ongoing peptic ulcer and constipation. 6. Planned vaccination during the time course of the study. 7. Taking any clinical investigation drug from 3 months before the study. 8. Use of any medication, including herb medicine or vitamins from 4 weeks before the study. 9. 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. 10. A positive Hepatitis B surface antigen or positive Hepatitis C antibody result. 11. A positive test for HIV(Human immunodeficiency virus) antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC 0- : Area under the plasma concentration-time curve from time zero to infinity determined by the trapezoidal rule and extrapolated to infinity estimated by the last quantifiable concentration (Cn) divided by kel | One month |
| AUMC : Area under the ( first) moment plasma concentration - time curve | One month |
| AUC 0-t: Area under the plasma concentration-time curve from zero to the last quantifiable concentration determined by the traperoidal rule | One month |
| Cmax: Peak drug concentration obtained directly from the data without interpolation | One month |
| kel:Plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration | One month |
| Tmax:Time to peak drug concentration obtained directly from the data without interpolation | One month |
| T 1/2: Plasma half-life estimated by (0.693/kel) | One month |
| MRT : Mean residence time | One month |
Secondary
| Measure | Time frame |
|---|---|
| heart rate | one month |
| body temperature | One month |
| 12 Laed ECG, Lab Test ( Hematocrit, WBC count with differential, RBC count and platelet count ; SGOT ( AST), SGPT (ALT) , alkaline phosphatase, total bilirubin, albumin, glucose, BUN, creatinine,uric acid, total cholesterol and TG) | One month |
| Blood pressure | one month |
Countries
Taiwan
Outcome results
None listed