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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 is a Phase 1 study that has completed, run by TaiGen Biotechnology Co.. The registered enrollment target is 24 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02108418
The ClinicalTrials.gov registry entry for NCT02108418 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TaiGen Biotechnology Co., which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TG-2349 as the original formulation is the first listed.
NCT02108418 reports 0 study locations.
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.
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