Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism, Excretion of DA-1229

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-01-31

Brief Summary

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The objectives of this study are to evaluate the absolute bioavailability, and absorption and excretion of DA-1229, an IMP in clinical assessment for the treatment of T2DM. The oral and IV PK of DA-1229 will also be evaluated. The metabolism of DA-1229 may also be evaluated.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Part 1

Single oral therapeutic dose of 5mg DA-1229 as a tablet + An IV dose of 20㎍ \[14C\]-DA-1229

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

Part 2

Single oral therapeutic dose of 5mg \[14C\]-DA-1229

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

Interventions

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DA-1229

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males
* Age 18 to 55
* BMI 18.0 to 30.0 kg/㎡

Exclusion Criteria

* History of any drug or alcohol abuse in the past 2years
* Regular alcohol consumption nin males \>21 units per week
* Current smokers and those who have smoked within the last 12months
* Radiation Exposure
* Positive drugs of abuse test result
* Positive HBsAg, HCV Ab, HIV results
* Serious adverse reaction or hypersensitivity to any drug of the formulation excipients
* Clinically significant allergy
* Donation of loss of blood within the previous 3 months
* Taking any prescribed or OTC drug or herbal remedies in the 14days before IMP administration

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes