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Completed

NCT Number: NCT02180477

Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation in Healthy Male Volunteers

Study to investigate the relative bioavailability of UHAC 62 XX capsule and two different tablet formulations (TF1 and TF2), and to obtain data for rational design of a subsequent pivotal bioequivalence (BE) study between capsule and tablet formulations.

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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 meloxicam and/or salicylate (aspirin) and/or Non-steroidal anti-inflammatory drugs (NSAIDs)
  • History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
  • History of alcohol or drug abuse
  • Participation to another trial with an investigational drug within 4 months prior to the administration
  • Whole blood donation more than 400 ml within 3 months prior to the administration
  • 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 administration
  • Any medication within 10 days prior to the administration
  • Excessive physical activities within 7 days prior to the administration
  • Alcohol drinking within 3 days prior to the administration
  • 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 - TF1 tablet

Drug

UHAC 62 XX - TF2 tablet

Drug

UHAC 62 XX - capsules

Drug

Primary outcomes

  1. Cmax (Maximum observed concentration in plasma)

    Time frame: up to 72 hours after administration

  2. AUC 0-72hr (Area under the concentration-time curve in plasma from zero time to 72 hours)

    Time frame: up to 72 hours after administration

Secondary outcomes

  1. tmax (Time to reach maximum concentration)

    Time frame: up to 72 hours after administration

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

    Time frame: up to 72 hours after administration

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

    Time frame: up to 72 hours after administration

  4. MRT 0-t (Mean residence time in the body from zero time to the time of the last quantifiable drug concentration)

    Time frame: up to 72 hours after administration

  5. Number of patients with adverse events

    Time frame: up to 14 days after last administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation

Important dates

Study start
2001
Primary completion
2001
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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