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NCT02634034 · ClinicalTrials.gov registry record · Phase 1
A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers
A Phase 1 study, sponsored by Kowa Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02634034: Completed Phase 1 study, sponsored by Kowa Research Institute.
NCT02634034 is a Phase 1 study that has completed, run by Kowa Research Institute. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02634034, a Phase 1 study, has completed, sponsored by Kowa Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR) pitavastatin in healthy adult volunteers.
Primary Outcome
Area Under the Curve 0 to tau
Interventions
- DRUG A: NK-104-CR 8 mg
- DRUG B: Pitavastatin IR 4 mg
- DRUG C: Pitavastatin IR 8 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-12 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT02634034 record still lists
NCT02634034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which A: NK-104-CR 8 mg is the first listed.
NCT02634034 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02634034 about?
NCT02634034 is a clinical study titled "A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers". The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR) pitavastatin in healthy adult volunteers.
What is the current status of trial NCT02634034?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2015-12. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02634034?
The interventions under investigation include: A: NK-104-CR 8 mg (DRUG), B: Pitavastatin IR 4 mg (DRUG), C: Pitavastatin IR 8 mg (DRUG).
Who is sponsoring clinical trial NCT02634034?
This trial is sponsored by Kowa Research Institute, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02634034's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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