Bioequivalence Study of UHAC62XX Tablets Compared With Capsules in Healthy Volunteers

NCT02187575 | Completed Phase 1

• 1 other identifier: 107.259
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax (maximum observed concentration of the analyte in plasma)

  up to day 8

• AUC 0-τ (Area under the concentration time curve in plasma from zero time to 24 hours after 7-day administration)

  up to day 8

Secondary Outcomes (5)

• Tmax (Time to reach Cmax)

  up to day 8

• T1/2 (Terminal half-life in plasma)

  up to day 8

• MRT 0-τ (Mean residence time in the body after 7-day administration)

  up to day 8

• Cτ (Concentration of the analyte in plasma 24 hours after 7-day administration)

  up to day 8

• Number of patients with adverse events

  up to 20 days after final administration

Study Arms (2)

UHAC 62 XX tablet

EXPERIMENTAL

Drug: UHAC 62 XX tablet

UHAC 62 XX capsule

ACTIVE COMPARATOR

Drug: UHAC 62 XX capsule

Interventions

UHAC 62 XX tablet DRUG

UHAC 62 XX tablet

UHAC 62 XX capsule DRUG

UHAC 62 XX capsule

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age \>= 20 and \<= 35 years
• Weight: Body Mass Index \>= 18.5 and \< 25
• 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

You may not qualify if:

• History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
• History of hypersensitivity to UHAC 62 XX and/or salicylate (aspirin etc.) 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 trial
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 11, 2014
• Study Start: July 1, 2002
• Primary Completion: September 1, 2002
• Last Updated: July 14, 2014

Record last verified: 2014-07