Last updated: 11/07/2018 14:10:49
A Phase I Pharmacokinetic and Pharmacodynamic Study on the Potential Drug-Drug Interactions between Paroxetine and Alprazolam
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase I Pharmacokinetic and Pharmacodynamic Study on the Potential Drug-Drug Interactions between Paroxetine and Alprazolam
Trial description: A Phase I Pharmacokinetic and Pharmacodynamic Study on the Potential Drug-Drug Interactions between Paroxetine and Alprazolam
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:
Acute and repeated-dose effects of paroxetine, alprazolam and its combination of polysomnographic sleep: a double-blind cross-over placebo-controlled interaction study in healthy young subjects (c-i). Barbanoj, M J, Lorenzo, J L, Clos, S, Morte, A, Luque, A, and Dal-Re, R 16th Congress of the European Sleep Research Society 6/3/2002 Reykjavik; Iceland
Lack of pharmacologic interaction between paroxetine and alprazolam at steady state in healthy volunteers. Calvo G, Garcia-Gea C, Luque A, Morte A, Dal-Re R, Barbanoj M. J Clin Psychopharmacol 2004; 3: 268-76.
Medical condition
Mental Disorders
Product
paroxetine
Collaborators
Not applicable
Study date(s)
December 1999 to Invalid Date
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
Not applicable
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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