An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Food Effect on the Safety and the Pharmacokinetics of CKD-378 in Healthy Adult Volunteers

Chong Kun Dang Pharmaceutical1 site in 1 country31 target enrollmentNovember 8, 2024

ConditionsType 2 Diabetes Mellitus (T2DM)

InterventionsCKD-378 25/1000mg

DrugsCKD-378 25/1000mg

Overview

Phase: Phase 1
Intervention: CKD-378 25/1000mg
Conditions: Type 2 Diabetes Mellitus (T2DM)
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 31
Locations: 1
Primary Endpoint: AUCt of CKD-378
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a randomized, open-label, single dose, crossover study to evaluate the food effect of CKD-378 in healthy volunteers

Detailed Description

To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is 7 days. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Registry

clinicaltrials.gov

Start Date

November 8, 2024

End Date

December 19, 2024

Last Updated

11 months ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Individuals who is 19 years of age or older at the time of the screening visit
•Individuals who had 18.0 kg/m2 ≤ Body Mass Index(BMI) \< 30.0 kg/m2 and total body weight ≥ 50 kg BMI = Weight(kg)/ Height(m)2
•Individuals who do not have clinically meaningful congenital or chronic diseases and who do not have medical examination results (such as electroencephalogram, electrocardiogram, chest and gastroscopy or gastrointestinal radiography, if necessary) during screening visits
•Individuals determined by investigators to be suitable for testing as a result of diagnostic tests and electrocardiogram tests, such as hematology tests, blood chemistry tests, serum tests, urine tests, etc
•Individuals who agreed proper contraception during the study and did consent to not donation of sperm or eggs 7 days after the last dose of study drug
•Individuals who signed an informed consent form after being fully informed of the study prior to participation, including the objective and content

Exclusion Criteria

•Individuals who has a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of drugs or has a gastrointestinal disease
•Individuals who has used a drug metabolase-inducing and inhibiting drug such as barbitals within one month prior to the first dosing date or a drug that may interfere with this test within 10 days prior to the first administration of investigational product
•Individuals who had been administered investigational product from other clinical study or bioequivalence study within the 6 months prior to the first administration of investigational product
•Individuals who donated whole blood within the 8 weeks, or blood components within 2 weeks or had a blood transfusion within 4 weeks prior to the first administration of investigational product
•Individuals who meets the following conditions within one month prior to the first administration of investigational product
•Man: average alcohol consumption \> 21 cups/weeks
•Woman: average alcohol consumption \> 14 cups/weeks
•Smoking \> 20 cigarettes
•Patients with the following conditions
•Patients with hypersensitivity to investigational product or biguanide drugs