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Completed

NCT Number: NCT02183142

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

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

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobic, China, 7.5 mg

Drug

Mobic, Germany, 7.5 mg

Drug

Primary outcomes

  1. Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: Up to 96 hours after drug administration

  2. Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity)

    Time frame: Up to 96 hours after drug administration

Secondary outcomes

  1. Time to achieve Cmax (tmax)

    Time frame: Up to 96 hours after drug administration

  2. Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t)

    Time frame: Up to 96 hours after drug administration

  3. Terminal rate constant in plasma (λ)

    Time frame: Up to 96 hours after drug administration

  4. Terminal half-life of the analyte in plasma (t1/2)

    Time frame: Up to 96 hours after drug administration

  5. Mean residence time of the analyte (MRT)

    Time frame: Up to 96 hours after drug administration

  6. Apparent clearance of the analyte in plasma following extravascular administration (CL/F)

    Time frame: Up to 96 hours after drug administration

  7. Apparent volume of distribution following extravascular administration (Vd/F)

    Time frame: Up to 96 hours after drug administration

  8. Number of patients with clinically relevant changes from baseline in laboratory values

    Time frame: Baseline, up to day 5 after last drug administration

  9. Number of Participants with Adverse Events

    Time frame: Up to day 5 after last drug administration

  10. Number of patients with clinically relevant changes from baseline in physical examination (pulse rate, systolic and diastolic blood pressure)

    Time frame: Baseline, up to day 5 after last drug administration

  11. Global assessment of tolerability by investigator on a 4-point scale

    Time frame: Day 5 after last drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2001
First posted
Jul 8, 2014
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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