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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01361022
• Date of registration: 25/05/2011
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: To Assess the Bioequivalence of Brotizolam Tablets 250 Mcg vs. Lendormin Tablets 250 Mcg Administered to Healthy Adult Volunteers
• Scientific title: A Randomized, Single-dose, Two-way Cross-over Study to Assess the Bioequivalence of Lendormin Tablets 0.25 mg (Delpharm Reims) vs. Lendormin Tablets 0.25 mg (Synmosa Biopharma Co. Ltd.) Administered to Healthy Adult Volunteers
• Date of first enrolment: August 2011
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01361022
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Taiwan

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

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.



Age minimum: 20 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Brotizolam tablet

Drug: Lendormin tablet

Primary Outcome(s)

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 [Time Frame: One month]

Cmax: Peak drug concentration obtained directly from the data without interpolation [Time Frame: One month]

T 1/2: Plasma half-life estimated by (0.693/kel) [Time Frame: One month]

AUC 0-t: Area under the plasma concentration-time curve from zero to the last quantifiable concentration determined by the traperoidal rule [Time Frame: One month]

Tmax:Time to peak drug concentration obtained directly from the data without interpolation [Time Frame: One month]

kel:Plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration [Time Frame: One month]

AUMC : Area under the ( first) moment plasma concentration - time curve [Time Frame: One month]

MRT : Mean residence time [Time Frame: One month]

Secondary Outcome(s)

body temperature [Time Frame: One month]

heart rate [Time Frame: one month]

Blood pressure [Time Frame: 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) [Time Frame: One month]

Secondary ID(s)

263.511

Source(s) of Monetary Support

Please refer to primary and secondary sponsors