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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lendormin tablet; Drug: Brotizolam tablet

• Registration Number: NCT01361022
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-25
• Study First Submitted QC: 2011-05-25
• Study First Posted: 2011-05-26
• Study Start: 2011-08
• Primary Completion: 2011-11
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
AUC 0-t: Area under the plasma concentration-time curve from zero to the last quantifiable concentration determined by the traperoidal rule	One month
T 1/2: Plasma half-life estimated by (0.693/kel)	One month
MRT : Mean residence time	One month
Tmax:Time to peak drug concentration obtained directly from the data without interpolation	One month
AUMC : Area under the ( first) moment plasma concentration - time curve	One month
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

263.511.1 Boehringer Ingelheim Investigational Site; 🇨🇳 Taipei, Taiwan