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

NCT ID: NCT01361022

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brotizolam tablet

Brotizolam tablets 250mcg : at least 6 and 24 subjects will be enrolled in the pre-study and main study, respectively

Group Type ACTIVE_COMPARATOR

Brotizolam tablet

Intervention Type DRUG

Brotizolam tablet 250mc is administrated and compared

Lendormin tablet

Lendormin tablets 250mcg: at least 6 and 24 subjects will be enrolled in the pre-study and main study, respectively

Group Type EXPERIMENTAL

Lendormin tablet

Intervention Type DRUG

Lendormin tablet 250mc is administrated and compared

Interventions

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Lendormin tablet

Lendormin tablet 250mc is administrated and compared

Intervention Type DRUG

Brotizolam tablet

Brotizolam tablet 250mc is administrated and compared

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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263.511.1 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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263.511

Identifier Type: -

Identifier Source: org_study_id