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Completed

NCT Number: NCT03659149

Pharmacokinetics and Safety Profile of CKD-333

Compare the pharmacokinetic characteristics and safety between CKD-333 tablet and CKD-330, D086 combination

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul Saint Mary's Hospital

Seoul, South Korea

About this study

An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-333 and coadministration of CKD-330 and D086 in healthy male adults

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 19 aged and 45 aged in healthy male adult
  • Body weight more than 50kg and within ideal body weight ±20%

Exclusion criteria

  • Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness
  • Have a gastrointestinal disease history that can effect drug absorption or surgery
  • SBP(Systolic Blood pressure)≥140mmHg or SBP<90mmHg, DBP(Diastolic Blood Pressure(≥90mmHg or DBP<60mmHg

Treatment and study plan

CKD-333 formulation I

Drug

1 tablet administered before the breakfast(single-dose)

Other names: Test drug

CKD-333 formulation II

Drug

1 tablet administered before the breakfast(single-dose)

Other names: Test drug

CKD-330+D086

Drug

2 tablet administered before the breakfast(single-dose)

Other names: Reference drug

Primary outcomes

  1. AUCt(Area under the plasma drug concentration-time curve) PK of Candesartan, Amlodipine, Atorvastatin

    Time frame: 0~72hours

  2. Cmax(Maximum plasma concentration of the drug in plasma) of Candesartan, Amlodipine, Atorvastatin

    Time frame: 0~72hours

Secondary outcomes

  1. AUCinf(Area under the plasma concentration-time curve from time t to infinity) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin

    Time frame: 0~72hours

  2. Tmax(Time to reach the maximum concentration) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin

    Time frame: 0~72hours

  3. t1/2(Time for Cmax to drop in half) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin

    Time frame: 0~72hours

  4. CL/F(Apparent clearance) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin

    Time frame: 0~72hours

  5. Vd/F(Apparent volume of distribution) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin

    Time frame: 0~72hours

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

An Open-label, Randomized, Fasted, Single-dose, Three-way Crossover Study to Compare the Pharmacokinetics and Safety Between Administration of CKD-333 and Coadministration of CKD-330 and D086 in Healthy Male Adults

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 6, 2018
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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