Status:
UNKNOWN
Compare the Pharmacokinetics and Safety of CKD-333 With Co-administration CKD-330 and D090 in Healthy Male Adults
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Hypertension
Dyslipidemias
Eligibility:
MALE
19-45 years
Phase:
PHASE1
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 an...
Eligibility Criteria
Inclusion
- Healthy male adults aged 19 to 45 years
- Body weight more than 50kg and within ideal body weight ±20%
- signed informed consent form
Exclusion
- 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
- Systolic Blood pressure≥140mmHg or Systolic Blood pressure\<90mmHg, Diastolic Blood Pressure≥90mmHg or Diastolic Blood Pressure\<60mmHg
Key Trial Info
Start Date :
February 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 6 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03849287
Start Date
February 25 2019
End Date
April 6 2019
Last Update
February 22 2019
Active Locations (1)
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1
Seoul Saint Mary's Hospital
Seoul, South Korea