Status:

COMPLETED

Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions

Lead Sponsor:

Roxane Laboratories

Conditions:

Pain

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

Brief Summary

The objective of this study was to prove the bioequivalence of Oxymorphone Hydrochloride 10 mg Tablets under fasting conditions

Eligibility Criteria

Inclusion

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion

  • Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to oxymorphone hydrochloride or any comparable or similar product.

Key Trial Info

Start Date :

June 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2008

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT01210638

Start Date

June 1 2008

End Date

June 1 2008

Last Update

January 23 2018

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Novum Pharmaceutical Research Services

Houston, Texas, United States, 77042