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NCT01635972 · ClinicalTrials.gov registry record · Phase 1
Drug Interaction Study of Multiple Doses of Isavuconazole and a Single Dose of Bupropion
A Phase 1 study of Healthy Volunteers and Pharmacokinetics of Isavuconazole, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01635972: Completed Phase 1 study of Healthy Volunteers and Pharmacokinetics of Isavuconazole, sponsored by Astellas Pharma Global Development.
NCT01635972 is a Phase 1 study of Healthy Volunteers and Pharmacokinetics of Isavuconazole that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 24 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01635972, a Phase 1 study of Healthy Volunteers and Pharmacokinetics of Isavuconazole, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of bupropion.
Primary Outcome
Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to the last quantifiable concentration (AUClast), and maximum concentration(Cmax)
Conditions Studied
Interventions
- DRUG Isavuconazole
- DRUG bupropion hydrochloride
Study Locations (1)
Florida
- Clinical Pharmacology of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
What the finished NCT01635972 record still lists
NCT01635972 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Isavuconazole is the first listed.
NCT01635972 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01635972 about?
NCT01635972 is a clinical study titled "Drug Interaction Study of Multiple Doses of Isavuconazole and a Single Dose of Bupropion". The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of bupropion.
What is the current status of trial NCT01635972?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-06. Estimated completion is 2012-07.
What conditions does trial NCT01635972 study?
This clinical trial studies the following conditions: Healthy Volunteers, Pharmacokinetics of Isavuconazole, Pharmacokinetics of Bupropion.
What interventions are being tested in trial NCT01635972?
The interventions under investigation include: Isavuconazole (DRUG), bupropion hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01635972?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01635972 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01635972's enrollment target sits among peer trials
24 204th of 283 higher than 66 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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