A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-389 in Healthy Volunteers Under Fasting Conditions

Chong Kun Dang Pharmaceutical1 site in 1 country34 target enrollmentApril 6, 2020

ConditionsType 2 Diabetes

InterventionsReference drug Test drug

DrugsReference drug Test drug

Overview

Phase: Phase 1
Intervention: Reference drug
Conditions: Type 2 Diabetes
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 34
Locations: 1
Primary Endpoint: AUCt(Area Under Curve last)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a randomized, open-label, fasted, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-389 in healthy volunteers.

Detailed Description

To healthy subjects of thirty-four (34), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug(D759 and D308), Test drug(CKD-389) Pharmacokinetic blood samples are collected up to 48 hrs. The pharmacokinetic characteristics and safety are assessed.

Registry

clinicaltrials.gov

Start Date

April 6, 2020

End Date

May 18, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adults over the age of 19 years and under the age of 65 years at the time of screening
•Subject who had 17.5kg/m² ≤ Body Mass Index (BMI) \< 30.5kg/m² and a total body weight of males ≥ 55 kg and females ≥ 45 kg
•# BMI=Weight(kg) / Height(m)²
•Subject without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
•Subject who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG etc.)
•Subject who signed an informed consent form approved by the Institutional Review Board(IRB) of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational drug
•Subject who consents to the use of reliable contraception during the clinical trial and not to donate his sperm during the study period and until 1 month after the last administration of investigational product
•Subject with the ability and willingness to participate during the study period

Exclusion Criteria

•Subjects 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 disease
•Subjects 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
•Subjects with the following laboratory test result:
•☞ ALT or AST \> 2x the upper limit of the normal range
•History of regular alcohol consumption exceeding 210 g/week within 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)
•Subjects who smoked more than 20 cigarettes per day within 6 months prior to screening
•Subjects who had been administered investigational product(s) from other clinical study or bioequivalence study within 6 months prior to the first dose of this study
•Following vital signs at screening
•☞ Sitting systolic blood pressure ≥160 mmHg or \<90 mmHg and/or a sitting diastolic blood pressure ≥100 mmHg or \<50 mmHg at screening
•Subjects with a medical history of significant alcohol or drug abuse within one year prior to the screening