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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Mobic, China, 7.5 mg; Drug: Mobic, Germany, 7.5 mg

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Number of Participants with Adverse Events	Up to day 5 after last drug administration
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 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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2001
• Primary Completion (Actual): April 1, 2001

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Meloxicam
• Other Study ID Numbers: 107.234