NCT00460785

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2007

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 16, 2007

Completed
Last Updated

July 6, 2007

Status Verified

March 1, 2007

First QC Date

March 28, 2007

Last Update Submit

July 5, 2007

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.

Secondary Outcomes (1)

  • Descriptive, e. g. safety/tolerability of Test comparable to Reference

Interventions

OpioidDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Standard Phase I
  • Cyp 2D6 extensive metabolizers

You may not qualify if:

  • Standard Phase I
  • Contraindications of current reference tablet SmPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Analgesics, Opioid

Intervention Hierarchy (Ancestors)

NarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Wolfgang Timmer, Dr.

    CRS Mannheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 28, 2007

First Posted

April 16, 2007

Study Start

February 1, 2007

Study Completion

March 1, 2007

Last Updated

July 6, 2007

Record last verified: 2007-03