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A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fasting Conditions

NCT05703984 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-01-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fasting conditions to healthy adult volunteers.

Conditions

  • Healthy Volunteers

Interventions

DRUG

GC2129A(Period 1)

Linagliptin and Metformin Hydrochloride Tablet

DRUG

Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)

Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)

DRUG

GC2129A(Period 2)

Linagliptin and Metformin Hydrochloride Tablet

DRUG

Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)

Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)

Sponsors & Collaborators

  • GC Biopharma Corp

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-17
Primary Completion
2023-04-19
Completion
2023-04-19

Countries

  • South Korea

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 NCT05703984 on ClinicalTrials.gov