NCT05729386

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

February 6, 2023

Last Update Submit

February 6, 2023

Conditions

Healthy Volunteers

Keywords

PKGC2129A

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic (PK) parameters - Cmax

    Pharmacokinetic (PK) parameters of Metformin in serum

    0-48hours

  • Pharmacokinetic (PK) parameters - AUCt

    Pharmacokinetic (PK) parameters of Metformin in serum

    0-48hours

Secondary Outcomes (3)

  • Pharmacokinetic (PK) parameters - AUCinf

    0-48hours

  • Pharmacokinetic (PK) parameters - Tmax

    0-48hours

  • Pharmacokinetic (PK) parameters - t1/2

    0-48hours

Study Arms (2)

GC2129A + Reference drugs

EXPERIMENTAL

Period 1: GC2129A, Period 2: Individual Components

Drug: GC2129A(Period 1)Drug: Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)

Reference drugs + GC2129A

EXPERIMENTAL

Period 1: Individual Components, Period 2: GC2129A

Drug: Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)Drug: GC2129A(Period 2)

Interventions

GC2129A(Period 1)DRUG

Linagliptin and Metformin Hydrochloride Tablet

GC2129A + Reference drugs
Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)DRUG

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

Reference drugs + GC2129A
GC2129A(Period 2)DRUG

Linagliptin and Metformin Hydrochloride Tablet

Reference drugs + GC2129A
Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)DRUG

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

GC2129A + Reference drugs

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A person who is 19 years of age or older at the time of a screening visit
  • A person with a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less with a weight of 50 kg or more (45 kg or more for women) during a screening visit
  • A person who has no clinically significant congenital or chronic disease during a screening visit and has no pathological symptoms or findings as a result of internal examination

You may not qualify if:

  • Persons with clinically significant diseases or history of the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and urinary reproductive system, mental and nervous system, musculoskeletal system, immune system, otolaryngology, skin system, and ophthalmology.
  • A person who has a history of gastrointestinal surgery
  • Those who have taken drug metabolism enzymes, such as barbiturate drugs, within one month of the first dose date or who have taken drugs that may interfere with this clinical trial within 10 days of the first dose date
  • A person who participates in another clinical trial or biological equivalence test within six months of the first administration date
  • A person who has donated whole blood within 8 weeks of the date of first administration, or has donated components within 2 weeks, or has received a blood transfusion within 4 weeks
  • In the case of female volunteers, a pregnant woman or pregnant woman is suspected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H Plus YangJi Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

GC Biopharma Corp.

CONTACT

82-(0)31-260-1934juyeon.kim@gccorp.com

GC Biopharma Corp.

CONTACT

82-(0)31-260-9318yumi@gccorp.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: An open-label, randomized, fed, single-dose, 2-group, 2-period, crossover design
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 15, 2023

Study Start

February 6, 2023

Primary Completion

April 17, 2023

Study Completion

April 17, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations

KR(1)