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

NCT02108418 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-12-19

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

DRUG

TG-2349 as the original formulation

single oral dose under fed condition

DRUG

TG-2349 as a new capsule formulation

single oral dose under fed condition

Sponsors & Collaborators

  • TaiGen Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Nicole Sims, DO · WCCT

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-06-30
Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02108418 on ClinicalTrials.gov