Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions

Pain Clinical Trial

Official title:

A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxymorphone Hydrochloride IR 10 mg Tablets, With a Naltrexone Block, Under Fasted Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210638
• Other study ID #: OXYM-T10-PVFS-1
• Status: Completed
• Phase: Phase 1
• First received: September 27, 2010
• Last updated: January 19, 2018
• Start date: June 2008
• Est. completion date: June 2008

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Oxymorphone
10 mg tablet

Locations

Country	Name	City	State
United States	Novum Pharmaceutical Research Services	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bioequivalence determined by statistical comparison Cmax		9 days