Clinical trial NCT03849287: Compare the Pharmacokinetics and Safety of CKD-333 With Co-administration CKD-330 and D090 in Healthy Male Adults
Official title: 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 D090 in Healthy Male Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hypertension
Dyslipidemias
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-02-21
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The object of clinical trial is to investigate the pharmacokinetics and safety compared to CKD-333 and co-administration CKD-330, D090 under fasting condition in healthy male adults.

Detailed description: 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 D090 in healthy male adults

Eligibility criteria: Inclusion Criteria:

1. Healthy male adults aged 19 to 45 years
2. Body weight more than 50kg and within ideal body weight ±20%
3. signed informed consent form

Exclusion Criteria:

1. Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness
2. Have a gastrointestinal disease history that can effect drug absorption or surgery
3. Systolic Blood pressure≥140mmHg or Systolic Blood pressure\<90mmHg, Diastolic Blood Pressure≥90mmHg or Diastolic Blood Pressure\<60mmHg

Primary outcomes:
measure: AUClast of Candesartan
timeFrame: 0 hour ~ 72 hour after drug administration
measure: AUClast of Amlodipine
timeFrame: 0 hour ~ 72 hour after drug administration
measure: AUClast of Atorvastatin
timeFrame: 0 hour ~ 72 hour after drug administration
measure: Cmax of Candesartan
timeFrame: 0 hour ~ 72 hour after drug administration
measure: Cmax of Amlodipine
timeFrame: 0 hour ~ 72 hour after drug administration
measure: Cmax of Atorvastatin
timeFrame: 0 hour ~ 72 hour after drug administration
Secondary outcomes:
measure: AUCinf of Candesartan
timeFrame: 0 hour ~ 72 hour after drug administration
measure: AUCinf of Amlodipine
timeFrame: 0 hour ~ 72 hour after drug administration
measure: AUCinf of Atorvastatin
timeFrame: 0 hour ~ 72 hour after drug administration
measure: AUCinf of 2-hydroxy atorvastatin
timeFrame: 0 hour ~ 72 hour after drug administration
measure: Tmax of Candesartan
timeFrame: 0 hour ~ 72 hour after drug administration
measure: Tmax of Amlodipine
timeFrame: 0 hour ~ 72 hour after drug administration
measure: Tmax of Atorvastatin
timeFrame: 0 hour ~ 72 hour after drug administration
measure: Tmax of 2-hydroxy atorvastatin
timeFrame: 0 hour ~ 72 hour after drug administration
measure: T1/2 of Candesartan
timeFrame: 0 hour ~ 72 hour after drug administration
measure: T1/2 of Amlodipine
timeFrame: 0 hour ~ 72 hour after drug administration
measure: T1/2 of Atorvastatin
timeFrame: 0 hour ~ 72 hour after drug administration
measure: T1/2 of 2-hydroxy atorvastatin
timeFrame: 0 hour ~ 72 hour after drug administration
measure: clearance of Candesartan
timeFrame: 0 hour ~ 72 hour after drug administration
measure: clearance of Amlodipine
timeFrame: 0 hour ~ 72 hour after drug administration
measure: clearance of Atorvastatin
timeFrame: 0 hour ~ 72 hour after drug administration
measure: clearance of 2-hydroxy atorvastatin
timeFrame: 0 hour ~ 72 hour after drug administration
measure: Vd/F of Candesartan
timeFrame: 0 hour ~ 72 hour after drug administration
measure: Vd/F of Amlodipine
timeFrame: 0 hour ~ 72 hour after drug administration
measure: Vd/F of Atorvastatin
timeFrame: 0 hour ~ 72 hour after drug administration
measure: Vd/F of 2-hydroxy atorvastatin
timeFrame: 0 hour ~ 72 hour after drug administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
Study officials:
affiliation: Department of Clinical Pharmacology, Seoul ST.Mary's Hospital
name: Seunghun Han, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: