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Completed

NCT Number: NCT02180490

Bioequivalence Study of UHAC 62 XX Tablets Compared With Capsules in Healthy Volunteers

Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) in fasted state.

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Key information

Conditions

Age range

20 year–35 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

  • Age >= 20 and <= 35 years
  • Weight: BMI >= 18.5 and < 25 (Weight (kg) / Height (m²)
  • Subjects who are judged by the investigator to be appropriate as the subjects of the study based on results of screening test
  • Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent

Exclusion criteria

  • History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
  • History of hypersensitivity to UHAC 62 XX and/or salicylate (aspirin) and/or Non-steroidal anti-inflammatory drugs (NSAIDs)
  • History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
  • History of bleeding tendency
  • History of alcohol or drug abuse
  • Participation to another trial with an investigational drug within 4 months prior to the trial
  • Whole blood donation more than 400 ml within 3 months prior to the trial
  • Whole blood donation more than 100 ml within 1 month prior to the administration
  • Donation of constituent of blood of more than 400 ml within 1 month prior to the trial
  • Any medication which might influence the results of the trial within 10 days prior to the trial
  • Excessive physical activities within 7 days prior to the trial
  • Alcohol drinking within 3 days prior to the trial
  • History of orthostatic hypotension, fainting spells or blackouts
  • Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study

Treatment and study plan

UHAC 62 XX tablet

Drug

UHAC 62 XX capsule

Drug

Primary outcomes

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

    Time frame: up to 60 hours after drug administration

  2. AUC 0-60hr (Area under the concentration time curve of the analyte in plasma from zero time to 60 hours)

    Time frame: up to 60 hours after drug administration

Secondary outcomes

  1. Tmax (Time to reach Cmax)

    Time frame: up to 60 hours after drug administration

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

    Time frame: up to 60 hours after drug administration

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

    Time frame: up to 60 hours after drug administration

  4. MRT 0-infinity (Mean residence time of the analyte molecules in the body from zero time to infinity)

    Time frame: up to 60 hours after drug administration

  5. Number of patients with adverse events

    Time frame: up to 20 days after final drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Bioequivalence Study of UHAC 62 XX 10 mg Tablets Compared With 10 mg Capsules Following Single Peroral Administration in Healthy Volunteers (An Open-label, Randomised, Two-way Crossover Study)

Important dates

Study start
2002
Primary completion
2002
First posted
Jul 2, 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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