Bioequivalence Trial of a New Opioid Combination Compared to Reference

Phase 1 Single Center Trial to Demonstrate the Bioequivalence of a New Combination Analgesic Formulation as Compared to an Equimolar Marketed Formulation

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00460785

Enrollment

Registered

2007-04-16

Start date

2007-02-28

Completion date

2007-03-31

Last updated

2007-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference

Interventions

DRUGOpioid

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Standard Phase I * Cyp 2D6 extensive metabolizers

Exclusion criteria

* Standard Phase I * Contraindications of current reference tablet SmPC

Design outcomes

Primary

Measure	Time frame
Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.	—

Secondary

Measure	Time frame
Descriptive, e. g. safety/tolerability of Test comparable to Reference	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026