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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01361022
First received: May 25, 2011
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Lendormin tablet
Drug: Brotizolam tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Cmax: Peak drug concentration obtained directly from the data without interpolation [ Time Frame: One month ] [ Designated as safety issue: No ]
  • kel:Plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration [ Time Frame: One month ] [ Designated as safety issue: No ]
  • Tmax:Time to peak drug concentration obtained directly from the data without interpolation [ Time Frame: One month ] [ Designated as safety issue: No ]
  • T 1/2: Plasma half-life estimated by (0.693/kel) [ Time Frame: One month ] [ Designated as safety issue: No ]
  • MRT : Mean residence time [ Time Frame: One month ] [ Designated as safety issue: No ]
  • AUMC : Area under the ( first) moment plasma concentration - time curve [ Time Frame: One month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: one month ] [ Designated as safety issue: No ]
  • heart rate [ Time Frame: one month ] [ Designated as safety issue: No ]
  • body temperature [ Time Frame: One month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: August 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brotizolam tablet
Brotizolam tablets 250mcg : at least 6 and 24 subjects will be enrolled in the pre-study and main study, respectively
Drug: Brotizolam tablet
Brotizolam tablet 250mc is administrated and compared
Experimental: Lendormin tablet
Lendormin tablets 250mcg: at least 6 and 24 subjects will be enrolled in the pre-study and main study, respectively
Drug: Lendormin tablet
Lendormin tablet 250mc is administrated and compared

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361022

Locations
Taiwan
263.511.1 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01361022     History of Changes
Other Study ID Numbers: 263.511
Study First Received: May 25, 2011
Last Updated: October 31, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Brotizolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014