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

Healthy Volunteers Clinical Trial

Official title:

Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of GC2129A in Healthy Adult Volunteers Under Fasting Conditions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703984
• Other study ID #: GC2129A_BE_FAST_P0101
• Status: Recruiting
• Phase: Phase 1
• Start date: January 17, 2023
• Est. completion date: April 19, 2023

Study information

• Verified date: January 2023
• Source: GC Biopharma Corp
• Contact: GC Biopharma Corp.
• Phone: 82-(0)31-260-1934
• Email: juyeon.kim[@]gccorp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is an open-label, randomized, fasting, single-dose, 2-group, 2-period, crossover design to evaluate pharmacokinetics that are not affected by blinding. According to the order of administering the investigational drug for each period, 25 people are assigned to each of the two groups and administered.

For healthy subjects, each 25 subjects are assigned to each of the two groups(total 50 subjects). If the subject administrate GC2129A in the first stage, the subject will be administrated reference drugs in the second stage after washout(over 7 weeks). Conversely, if the subject administrate reference drugs in the first stage, the subject will be administrated with GC2129A in the second stage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 19, 2023
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• A person who is deemed unsuitable for participation in this clinical trial by the principle investigator(or the delegated sub-investigator) for reasons other than the above selection and exclusion criteria

• In the case of female volunteers, a pregnant woman or pregnant woman is suspected

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• GC2129A(Period 1)
Linagliptin and Metformin Hydrochloride Tablet
• Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)
Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)
• GC2129A(Period 2)
Linagliptin and Metformin Hydrochloride Tablet
• Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)
Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)

Locations

Country	Name	City	State
Korea, Republic of	H Plus YangJi Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GC Biopharma Corp

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic (PK) parameters - Cmax	Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum	0-72hours
Primary	Pharmacokinetic (PK) parameters - AUCt	Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum	0-72hours
Secondary	Pharmacokinetic (PK) parameters - AUCinf	Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum	0-72hours
Secondary	Pharmacokinetic (PK) parameters - Tmax	Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum	0-72hours
Secondary	Pharmacokinetic (PK) parameters - t1/2	Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum	0-72hours