A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-387 in Healthy Volunteers Under Fasting Conditions

Chong Kun Dang Pharmaceutical1 site in 1 country37 target enrollmentSeptember 16, 2022

ConditionsEndocrine, Nutritional and Metabolic Diseases

InterventionsCKD-387 D484

DrugsCKD-387 D484

Overview

Phase: Phase 1
Intervention: CKD-387
Conditions: Endocrine, Nutritional and Metabolic Diseases
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 37
Locations: 1
Primary Endpoint: AUCt of CKD-387, D484
Status: Completed
Last Updated: last year

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 pharmacokinetic profiles and safety of CKD-387 in healthy volunteers under fasting conditions.

Detailed Description

To 36 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Registry

clinicaltrials.gov

Start Date

September 16, 2022

End Date

October 9, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adults volunteers aged between 19 and 55 years old at the time of screening
•Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) \< 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg
•\* BMI = Weight(kg)/ Height(m)2
•Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
•Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed at screening
•Individuals who signed an informed consent form approved by the Institutional Review Board of Bumin Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective and content
•Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
•Individuals with the ability and willingness to participate the entire study period

Exclusion Criteria

•Individuals with a medical evidence or a history (excluding a dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune diseases.
•Individuals with a medical history of gastrointestinal disease (e.g., gullet disease such as esophageal achalasia and esophagostenosis and Crohn's disease) or operations (excluding simple appendectomy, herniotomy or tooth extraction) that may affect drug absorption
•Individuals with the following laboratory test results at screening:
•Alanine aminotransferase or Aspartate transaminase \> 2x the upper limit of the normal range
•History of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
•Individuals who smoked more than 20 cigarettes per day within 6 months or consumed more than 5 cups of caffeine per day prior to first administration of investigational drugs
•Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first administration of investigational drugs
•Following vital signs results at screening
•Sitting systolic blood pressure ≥ 150 mmHg or \< 90 mmHg and/or sitting diastolic blood pressure ≥100 mmHg or \<50 mmHg
•Individuals with a medical history of significant alcohol or drug abuse within one year prior to the screening