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CompletedNCT01361022Updated Nov 1, 2013

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

A Phase 1 interventional study of Lendormin tablet and Brotizolam tablet in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-01.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugLendormin tablet

    Lendormin tablet 250mc is administrated and compared

  • DrugBrotizolam tablet

    Brotizolam tablet 250mc is administrated and compared

06

What researchers measure

Primary outcomes

  1. Cmax: Peak drug concentration obtained directly from the data without interpolation

    Time frame: One month

  2. kel:Plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration

    Time frame: One month

  3. Tmax:Time to peak drug concentration obtained directly from the data without interpolation

    Time frame: One month

  4. T 1/2: Plasma half-life estimated by (0.693/kel)

    Time frame: One month

  5. MRT : Mean residence time

    Time frame: One month

  6. AUMC : Area under the ( first) moment plasma concentration - time curve

    Time frame: One month

  7. 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

  8. 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

Secondary outcomes

  1. Blood pressure

    Time frame: one month

  2. heart rate

    Time frame: one month

  3. body temperature

    Time frame: One month

  4. 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

07

Study locations

1 site
  • 263.511.1 Boehringer Ingelheim Investigational Site
    Taipei, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01361022
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
May 26, 2011
Start date
Aug 2011
Primary completion
Nov 2011
Last update
Nov 1, 2013

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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