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NCT02108418 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the PK, Relative Bioavailability and Safety of TG-2349 With Single Oral Dose Under Fed Condition in Healthy Volunteers
A Phase 1 study, sponsored by TaiGen Biotechnology Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02108418: Completed Phase 1 study, sponsored by TaiGen Biotechnology Co..
NCT02108418 is a Phase 1 study that has completed, run by TaiGen Biotechnology Co.. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02108418, a Phase 1 study, has completed, sponsored by TaiGen Biotechnology Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
1. To evaluate the pharmacokinetics (PK) and relative bioavailability of TG-2349, given as a new capsule formulation and as the original formulation of oral solution, after a single oral dose of 400 mg under fed condition in healthy volunteers. 2. To evaluate the safety and tolerability of TG-2349 in healthy volunteers. 3. To evaluate the ethnic differences in PK and safety between East Asian and Caucasian volunteers.
Interventions
- DRUG TG-2349 as the original formulation
- DRUG TG-2349 as a new capsule formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-04 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT02108418 record still lists
NCT02108418 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which TG-2349 as the original formulation is the first listed.
NCT02108418 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02108418 about?
NCT02108418 is a clinical study titled "Study to Evaluate the PK, Relative Bioavailability and Safety of TG-2349 With Single Oral Dose Under Fed Condition in Healthy Volunteers". 1. To evaluate the pharmacokinetics (PK) and relative bioavailability of TG-2349, given as a new capsule formulation and as the original formulation of oral solution, after a single oral dose of 400 mg under fed condition in healthy volunteers. 2. To evaluate the safety and tolerability of TG-2349 i...
What is the current status of trial NCT02108418?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2014-04. Estimated completion is 2014-07.
What interventions are being tested in trial NCT02108418?
The interventions under investigation include: TG-2349 as the original formulation (DRUG), TG-2349 as a new capsule formulation (DRUG).
Who is sponsoring clinical trial NCT02108418?
This trial is sponsored by TaiGen Biotechnology Co., which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02108418's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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