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NCT03340753 · ClinicalTrials.gov registry record · Phase 1
Bioavailability of KBP-5074 Tablet vs Capsule Formulations
A Phase 1 study, sponsored by KBP Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT03340753 is a Phase 1 study that has completed, run by KBP Biosciences. The registered enrollment target is 20 participants.
The verdict
NCT03340753, a Phase 1 study, has completed, sponsored by KBP Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is an open-label, partial crossover, single-dose study to evaluate the pharmacokinetics (PK), dose proportionality, and safety/tolerability of tablet versus capsule formulations of KBP-5074 in healthy subjects. The study is designed to evaluate the PK of a new tablet formulation versus that of the current capsule formulation. Data derived from this study, in addition to preclinical data and chemistry, manufacturing, and controls, will provide a basis for dose selection in future studies.
Interventions
- DRUG KBP-5074 Capsule
- DRUG KBP-5074 Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-10-26 |
| Est. Completion | 2017-12-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03340753
The ClinicalTrials.gov registry entry for NCT03340753 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is KBP Biosciences, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which KBP-5074 Capsule is the first listed.
NCT03340753 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03340753 about?
NCT03340753 is a clinical study titled "Bioavailability of KBP-5074 Tablet vs Capsule Formulations". This is an open-label, partial crossover, single-dose study to evaluate the pharmacokinetics (PK), dose proportionality, and safety/tolerability of tablet versus capsule formulations of KBP-5074 in healthy subjects. The study is designed to evaluate the PK of a new tablet formulation versus that of ...
What is the current status of trial NCT03340753?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2017-10-26. Estimated completion is 2017-12-19.
What interventions are being tested in trial NCT03340753?
The interventions under investigation include: KBP-5074 Capsule (DRUG), KBP-5074 Tablet (DRUG).
Who is sponsoring clinical trial NCT03340753?
This trial is sponsored by KBP Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.
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