Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions

Roxane Laboratories

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Oxymorphone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01210638

OXYM-T10-PVFS-1

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Oxymorphone Hydrochloride

Active Comparator group

Description:

Tablet

Treatment:

Drug: Oxymorphone

Opana

Active Comparator group

Description:

Tablet

Treatment:

Drug: Oxymorphone