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NCT01188668 · ClinicalTrials.gov registry record · Phase 4
Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects
A Phase 4 study of Pharmacokinetics and Cytochrome P-450 CYP2D6, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
- 2
- Study locations
NCT01188668: Completed Phase 4 study of Pharmacokinetics and Cytochrome P-450 CYP2D6, sponsored by Pfizer.
NCT01188668 is a Phase 4 study of Pharmacokinetics and Cytochrome P-450 CYP2D6 that has completed, run by Pfizer. The registered enrollment target is 38 participants, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (38% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01188668, a Phase 4 study of Pharmacokinetics and Cytochrome P-450 CYP2D6, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine Sustained Release (SR) on the pharmacokinetics of Aripiprazole when coadministered to healthy adult subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Aripiprazole when coadministered to healthy adult subjects.
Primary Outcome
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng\*hr/mL).
Conditions Studied
Interventions
- DRUG Aripiprazole
- DRUG Aripiprazole + desvenlafaxine succinate sustained release
Study Locations (2)
Florida
- Pfizer Investigational Site - Miami
- Pfizer Investigational Site - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2010-08 |
| Est. Completion | 2010-10 |
| Phase | Phase 4 |
What the finished NCT01188668 record still lists
NCT01188668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (38% lower).
The record links to 3 conditions, with Pharmacokinetics appearing as the primary indexed condition, and to 2 interventions - of which Aripiprazole is the first listed.
NCT01188668 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01188668 about?
NCT01188668 is a clinical study titled "Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects". The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine Sustained Release (SR) on the pharmacokinetics of Aripiprazole when coadministered to healthy adult subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Aripiprazole when coad...
What is the current status of trial NCT01188668?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2010-08. Estimated completion is 2010-10.
What conditions does trial NCT01188668 study?
This clinical trial studies the following conditions: Pharmacokinetics, Cytochrome P-450 CYP2D6, CYP3A4 Protein, Human.
What interventions are being tested in trial NCT01188668?
The interventions under investigation include: Aripiprazole (DRUG), Aripiprazole + desvenlafaxine succinate sustained release (DRUG).
Who is sponsoring clinical trial NCT01188668?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01188668 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01188668's enrollment target sits among peer trials
38 13th of 37 higher than 25 of 37 other Pharmacokinetics trials
participants (enrollment target), bucketed by value
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