Last updated: 11/07/2018 16:10:21
A Phase I, 13-Day, Controlled, Open-Label Pharmacokinetic Evaluation of Methadone Following Co-Administration with Amprenavir in Opiate-Dependent Subjects
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase I, 13-Day, Controlled, Open-Label Pharmacokinetic Evaluation of Methadone Following Co-Administration with Amprenavir in Opiate-Dependent Subjects
Trial description: A Phase I, 13-Day, Controlled, Open-Label Pharmacokinetic Evaluation of Methadone Following Co-Administration with Amprenavir in Opiate-Dependent Subjects
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Hendrix CW, Wakeford J, Wire MB, Lou Y, Bigelow GE, Martinez E, Christopher J, Fuchs EJ, Snidow JW. Pharmacokinetics and pharmacodynamics of methadone enantiomers after coadministration with amprenavir in opioid-dependent subjects. Pharmacotherapy. 24(9):1110-21, 2004 Sep.
Hendrix D, Wakeford J, Wire MB, Bigelow G, Cornell E, Christopher J, Fuchs E, Snidow J. Pharmacokinetic (PK) and Pharmacodynamic (PD) Evaluation of Methadone (MD) Enantiomers Following Co-Administration with Amprenavir (APV) in Opioid-dependent Subjects. Presented at the 40th Interscience Conference on Antimicrobial agents and Chemotherapy, Toronto, Ontario, Canada, September 17-20, 2000. Abstract 1649.
Medical condition
Infection, Human Immunodeficiency Virus
Product
amprenavir
Collaborators
Not applicable
Study date(s)
August 1999 to April 2000
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2000-07-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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