A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects

NCT01650324 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-08-28

Study results available
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Summary

The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties of single oral doses of DBPR108 in healthy male subjects.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

DBPR108

DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg.

DRUG

matching placebo

Matching placebo capsules in four doses beginning at 25 mg and rising to 600 mg.

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Taiwan

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 NCT01650324 on ClinicalTrials.gov