Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects

NCT05544214 | Completed Phase 1

• 1 other identifier: A127_01BE2206
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects

Conditions

Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-371, D745+D759

  Area under the CKD-371, D745+D759 concentration in blood-time curve from zero to final

  Pre-dose(0hr), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48hr

• Cmax of CKD-371, D745+D759

  The maximum CKD-388/D418 concentration in blood sampling time

  Pre-dose(0hr), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48hr

Study Arms (2)

Sequence 1

EXPERIMENTAL

Period 1 - A single dose of 2 tablets(D745, D759) under fasting condition. Period 2 - A single dose of 1 tablets(CKD-371) under fasting condition.

Drug: CKD-371

Sequence 2

EXPERIMENTAL

Period 1 - A single dose of 1 tablets(CKD-371) under fasting condition. Period 2 - A single dose of 2 tablets(D745, D759) under fasting condition.

Drug: CKD-371

Interventions

CKD-371 DRUG

PO

Also known as: D745, D759

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults volunteers aged between 19 and 45 years old at the time of screening
• Weight ≥50kg, with calculated body mass index (BMI) of 18.0 to 29.9 kg/m2 at the time of screening
• Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial

You may not qualify if:

• Those with clinically significant diseases or history in cardiovascular system, respiratory system, liver, kidney, hematological, gastrointestinal, endocrine system, immune system, skin system, mental/nervous system, etc
• Those who have symptoms of acute disease within 28 days of the the first dose of the investigational product
• Those who with a history of influencing drug absorption, distribution, metabolism, and excretion
• Those who have a hypersensitivity reaction or a history of clinically significant hypersensitivity reaction or a history of drug abuse inculding SGLT2 inhibitor class component or DPP 4 inhibitor class or same class component drugs containing ingredients
• Those with clinically significant active chronic disease
• Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption
• A person who has had one or more of the following results in screening tests including re-examination
• AST, ALT \> UNL (upper normal limit) x 2.5
• Fasting glucose \< 70 mg/dL
• Calculated by Cockcroft Gault formula Creatinine clearance is 75mL/min or less (Cockcroft Gault GFR = (140 age) \* (Wt in kg) / (72 \* Cr))
• QTc \> 470 msec as a result of ECG
• Urine-hCG test is positive(if it is limited to female subjects)
• Those who test positive for HBs Ag, HCV Ab, HIV Ab, or VDRL
• Those who have taken prescription medicine (ETCs), including prescription drugs, within 14 days of the first dose
• Those who have taken over-the-counter medicines (OTC) including herbal medicines within 7 days of the first dose

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: October 21, 2022
• Primary Completion: November 14, 2022
• Study Completion: November 17, 2022
• Last Updated: March 22, 2023

Record last verified: 2022-09

Locations

KR (1)