Bioequivalence Study of UH-AC 62 XX Tablets Compared With the Capsule Formulations in Healthy Volunteers

NCT02181907 | Completed Phase 1

• 1 other identifier: 107.260
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the bioequivalence of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX capsules 10 mg by single administration in healthy volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  up to 60 hours after drug administration

• 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 Outcomes (5)

• Tmax (Time to reach Cmax)

  up to 60 hours after drug administration

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

  up to 60 hours after drug administration

• 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

• MRTpo (Mean residence time of the analyte in the body after single dose po administration)

  up to 60 hours after drug administration

• Number of patients with adverse events

  up to 20 days after final drug administration

Study Arms (2)

UH-AC 62 XX tablet

EXPERIMENTAL

Drug: UH-AC 62 XX tablet; Drug: UH-AC 62 XX capsule

UH-AC 62 XX capsule

ACTIVE COMPARATOR

Drug: UH-AC 62 XX tablet; Drug: UH-AC 62 XX capsule

Interventions

UH-AC 62 XX tablet DRUG

UH-AC 62 XX capsule; UH-AC 62 XX tablet

UH-AC 62 XX capsule DRUG

UH-AC 62 XX capsule; UH-AC 62 XX tablet

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 to 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 UH-AC 62 XX (meloxicam) or salicylate (aspirin etc.) or Non-steroidal anti-inflammatory drugs (NSAIDs)
• History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
• A tendency of bleeding
• History of alcohol or drug abuse
• Taking 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 could 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 were 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 2, 2014
• First Posted: July 8, 2014
• Study Start: March 1, 2003
• Primary Completion: April 1, 2003
• Last Updated: July 8, 2014

Record last verified: 2014-07