ClinicalTrials.gg
CompletedNCT00460785Updated Jul 6, 2007

Bioequivalence Trial of a New Opioid Combination Compared to Reference

A Phase 1 interventional study of Opioid in Healthy, sponsored by Grünenthal GmbH. Completed. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-07-06.

Sponsored by Grünenthal GmbH · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Grünenthal GmbH is the lead sponsor of 68 studies on the registry; 2 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 8 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Standard Phase I
  • Cyp 2D6 extensive metabolizers

Exclusion criteria

Exclusion Criteria:

  • Standard Phase I
  • Contraindications of current reference tablet SmPC
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants

Interventions

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2007 and a completion of Mar 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2007
First posted
Apr 16, 2007
Start
Feb 2007
CompletionActual
Mar 2007
Last update
Jul 6, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 6, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00460785
Lead sponsor
Grünenthal GmbH
First posted
Apr 16, 2007
Start date
Feb 2007
Completion
Mar 2007
Last update
Jul 6, 2007

Study contacts

Wolfgang Timmer, Dr.
principal investigator · CRS Mannheim
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Analgesics, Opioid

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