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Completed Phase 1 Interventional Accepts healthy volunteers

Study to Evaluate the PK, Relative Bioavailability and Safety of TG-2349 With Single Oral Dose Under Fed Condition in Healthy Volunteers

ClinicalTrials.gov ID: NCT02108418

Public ClinicalTrials.gov record NCT02108418. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 11:31 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1, Randomized, Open-label, 2-way Crossover Study in Healthy East Asian and Caucasian Volunteers to Evaluate the Relative Bioavailability of A New Capsule Formulation of TG-2349 Compared to the Original Formulation of TG-2349 Oral Solution

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02108418
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
TaiGen Biotechnology Co., Ltd.
Industry
Enrollment
24 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 40 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2014
Primary completion
May 31, 2014
Completion
Jun 30, 2014
Last update posted
Dec 18, 2014

2014

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
WCCT Cypress California 90630

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02108418, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 18, 2014 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02108418 live on ClinicalTrials.gov.

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