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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02180490
Collaborator
(none)
60
Enrollment
2
Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: UHAC 62 XX tablet
  • Drug: UHAC 62 XX capsule
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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)
Study Start Date :
May 1, 2002
Actual Primary Completion Date :
Jul 1, 2002

Arms and Interventions

Arm Intervention/Treatment
Experimental: UHAC 62 XX tablet

Drug: UHAC 62 XX tablet

Drug: UHAC 62 XX capsule
Active Comparator: UHAC 62 XX capsule

Drug: UHAC 62 XX tablet

Drug: UHAC 62 XX capsule

Outcome Measures

Primary Outcome Measures

  1. Cmax (Maximum observed concentration of the analyte in plasma) [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) [up to 60 hours after drug administration]

Secondary Outcome Measures

  1. Tmax (Time to reach Cmax) [up to 60 hours after drug administration]

  2. t1/2 ( Terminal half-life of the analyte in plasma) [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) [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) [up to 60 hours after drug administration]

  5. Number of patients with adverse events [up to 20 days after final drug administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 35 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

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:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02180490
Other Study ID Numbers:
  • 107.252
First Posted:
Jul 2, 2014
Last Update Posted:
Jul 8, 2014
Last Verified:
Jul 1, 2014

Study Results

No Results Posted as of Jul 8, 2014