A Clinical Trial to Assess the Effects of Food on the Bioavailability of CKD-337

NCT03382756 | Completed Phase 1

• 1 other identifier: 146FDI17001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A cross-over, randomized and open-label clinical trial to evaluate the effects of food on the bioavailability of CKD-337 after a single oral dose in healthy male subjects

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (4)

• AUC0-t of Atorvastatin

  Area under the plasma concentration of Atorvastatin versus time curve from time zero to time of last quantifiable concentration

  Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration

• Cmax of Atorvastatin

  Maximum plasma concentration of Atorvastatin

  Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration

• AUCt of Fenofibric acid

  Area under the plasma concentration of Fenofibric acid versus time curve from time zero to time of last quantifiable concentration

  Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration

• Cmax of Fenofibric acid

  Maximum plasma concentration of Fenofibric acid

  Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration

Secondary Outcomes (17)

• AUCinf of Atorvastatin

  Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration

• Tmax of Atorvastatin

  Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration

• T 1/2 of Atorvastatin

  Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration

• CL/F of Atorvastatin

  Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration

• Vd/F of Atorvastatin

  Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration

Study Arms (2)

Group A

EXPERIMENTAL

Period 1: 1 capsule of test drug(CKD-337) administered under fasting condition Period 2: 1 capsule of test drug(CKD-337) under high fat diet condition

Dietary Supplement: High fat diet; Drug: CKD-337

Group B

EXPERIMENTAL

Period 1: 1 capsule of test drug(CKD-337) under high fat diet fed condition Period 2: 1 capsule of test drug (CKD-337) administered under fasting condition

Dietary Supplement: High fat diet; Drug: CKD-337

Interventions

High fat diet DIETARY_SUPPLEMENT

A diet consisting of more than 900kcal and 35% of fat

Group A; Group B

CKD-337 DRUG

Test Drug

Also known as: Atorvastatin Calcium Trihydrate + Choline Fenofibrate

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• Healthy male subjects between the ages of 19 and 45 years
• Body mass index between 17.5 and 30.5 kg/m², body weight more than 55kg
• Subject who doesn't have chronic disease, pathological symptoms or findings
• Subject who is suitable for the clinical trial determined by laboratory tests(serum test, hematology test, blood chemistry, urinalysis test etc.), Vital Sign, ECG test at the time of screening
• Subject who fully understand the clinical trial after in-depth explanation, decide to join the clinical trials and sign on an inform consent from willingly.

You may not qualify if:

• Subject who has a clinically significant disease such as hepatic, kidneys, neurological, respiratory, endocrine, hemato-oncology, urinary, cardiovascular, musculoskeletal or psychiatric diseases and who has medical histories listed below.
• Gallbladder disease including cholelithiasis, severe hepatic impairment
• Acute/chronic pancreatitis due to hypertriglyceridemia
• Pulmonary embolism or interstitial lung disease
• Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Hypoalbuminemia
• Alcoholics
• Predisposition to rhabdomyolysis
• Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption
• Subject who has hypersensitivity to the drugs containing choline fenofibrate, fenofibrate or atorvastatin, or other drugs such as aspirin, fenofibrate series, antibiotics
• Subject who has the following clinical significant findings in the EKG at the time of screening
• QTc(Q-T interval corrected for heart rate) \> 450ms
• PR interval(The interval between the beginning of the P wave and the beginning of the QRS complex in ECG) \> 200msec
• QRS duration(The duration of the QRS wave in ECG) \> 120msec
• Subject whose results of the clinical laboratory tests are included in the following categories

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Dong-A University Hospital

Busan, Seo-gu, 602-812, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Diet, High-Fat; Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Min Kyu Park, Professor

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

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: December 19, 2017
• First Posted: December 26, 2017
• Study Start: October 12, 2017
• Primary Completion: November 2, 2017
• Study Completion: November 7, 2017
• Last Updated: December 27, 2017

Record last verified: 2017-12

Locations

KR (1)