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A phase I study to investigate the linearity of fentanyl steady-state pharmacokinetics following dose-escalated multiple applications of a Fentanyl MDTS in healthy male volunteers in pain

A phase I study to investigate the linearity of fentanyl steady-state pharmacokinetics following dose-escalated multiple applications of a Fentanyl MDTS in healthy male volunteers in pain

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000527662
Enrollment
12
Registered
2005-09-26
Start date
2003-03-14
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Interventions

Fentanyl MDTS and Naltrexone for up to 21 days.

Sponsors

Acrux DDS Pty Ltd
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
0 to No maximum
Healthy volunteers
Yes

Inclusion criteria

Healthy volunteers

Exclusion criteria

No exclusion criteria

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026