Study of Relative Bioavailability of Mobic Manufactured in China in Comparison With Mobic Manufactured in Germany in Chinese Healthy Volunteers

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT02183142

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

Brief Summary

The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Mobic, China, 7.5 mg Drug: Mobic, Germany, 7.5 mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Relative Bioavailability of 7.5 mg Mobic Tablet Manufactured in China in Comparison With 7.5 mg Tablets Manufactured in Germany After a Single Oral Dose in Chinese Healthy Volunteers, Open, Randomized, Two Way Crossover Trial

Study Start Date :

Mar 1, 2001

Actual Primary Completion Date :

Apr 1, 2001

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mobic Germany	Drug: Mobic, China, 7.5 mg Drug: Mobic, Germany, 7.5 mg
Experimental: Mobic China	Drug: Mobic, China, 7.5 mg Drug: Mobic, Germany, 7.5 mg

Arm

Intervention/Treatment

Active Comparator: Mobic Germany

Drug: Mobic, China, 7.5 mg

Drug: Mobic, Germany, 7.5 mg

Experimental: Mobic China

Drug: Mobic, China, 7.5 mg

Drug: Mobic, Germany, 7.5 mg

Outcome Measures

Primary Outcome Measures

Maximum measured concentration of the analyte in plasma (Cmax) [Up to 96 hours after drug administration]
Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity) [Up to 96 hours after drug administration]

Secondary Outcome Measures

Time to achieve Cmax (tmax) [Up to 96 hours after drug administration]
Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t) [Up to 96 hours after drug administration]
Terminal rate constant in plasma (λ) [Up to 96 hours after drug administration]
Terminal half-life of the analyte in plasma (t1/2) [Up to 96 hours after drug administration]
Mean residence time of the analyte (MRT) [Up to 96 hours after drug administration]
Apparent clearance of the analyte in plasma following extravascular administration (CL/F) [Up to 96 hours after drug administration]
Apparent volume of distribution following extravascular administration (Vd/F) [Up to 96 hours after drug administration]
Number of patients with clinically relevant changes from baseline in laboratory values [Baseline, up to day 5 after last drug administration]
Number of Participants with Adverse Events [Up to day 5 after last drug administration]
Number of patients with clinically relevant changes from baseline in physical examination (pulse rate, systolic and diastolic blood pressure) [Baseline, up to day 5 after last drug administration]
Global assessment of tolerability by investigator on a 4-point scale [Day 5 after last drug administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Chinese healthy male volunteers as determined by result of screening
Written informed consent in accordance with Good Clinical Practice (GCP)
Age >= 18 and <= 40 years
Broca > - 20% and < + 20%

Exclusion Criteria:

Any finding of the medical examination (blood pressure, pulse rate and Electrocardiogram (ECG) deviating from normal and of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
Surgery of the gastro-intestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
Chronic or relevant acute infections
Hypersensitivity to Mobic and/or non-steroidal anti-inflammatory drugs
Intake any drugs within 1 month before randomization
Participation in another trial with an investigational drug within the last 2 month or during the trial
Smokers ( >= 10 cigarettes or >= 3 cigars or >= 3 pipes/day) or inability to refrain from smoking on study days
Alcohol or drug abuse
Blood donation within the last 1 month
Excessive physical activities within the last 5 days
History of hemorrhagic diatheses
History of gastro-intestinal ulcer, perforation or bleeding
History of bronchial asthma

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT02183142

Other Study ID Numbers:

107.234

First Posted:

Jul 8, 2014

Last Update Posted:

Jul 8, 2014

Last Verified:

Jul 1, 2014

Additional relevant MeSH terms:

Meloxicam

Study Results

No Results Posted as of Jul 8, 2014