The purpose of the study is examining and comparing the pharmacokinetic drug interaction and
safety of both single administration and combination administration of CKD-330 and D086 to
healthy male subjects
Drug: CKD-330 + D086
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT03017950
Ages eligible for Study
19 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
Healthy adult males age of between 19 - 45 on the day of screening.
Body mass index(BMI) between 18.0 - 29.0 kg/m^2 and weight ≥ 55kg (Body mass index
(BMI) = weight (kg) / height (m)^2)
Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.
Not abnormal or not clinically significant lab values.
Subjects who signed informed consent form with good understandings after explanations by investigators.
No history or presence of clinically significant cardiac, respiratory, neurological, endocrine, metal and renal diseases and liver and kidney diseases.
Subjects showing angioedema as an adverse reaction to ACE inhibitors
History or family history of myopathy
Subjects with mental diseases or drug addiction
Allergic reactions to candesartan or amlodipine or atorvastatin
Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
Hypotension(SBP ≤100mmHg or DBP≤55mnHg) or hypertension ( SNP ≥ 150mmHg, DBP ≥95mmHg) on the day of screening
Subjects who experienced gastrointestinal diseases or surgeries which can affect absorption of Investigational product
Subjects with abnormal lab values at least one below
(AST or ALT>2 fold of upper normal limit, Total bilirubin>2 fold of upper normal limit, CPK>2 fold of upper normal limit, K <3.5mEq/L or >5.5mEq/L, Estimated Glomerular filtration rate<60mL/min/1.73m2 by Modification)
Continuous drinking (over 21 units/week, 1 unit= 10g=12.5mL of pure alcohol), heavy smoker(> 10 cigarettes per day) and unable to stop drinking during clinical trials
Subjects who previously participated in other clinical trials within 90 days
Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
Subjects who were administered below medications within 30 days (cyclosporin, erythromycin, clarithromycin, lopinavir, ritonavir, itraconazole, ketoconazole, rifampicin, barbiturate : theses medicines could affect absorption, metabolism, distribution and excretion of candesartan,amlodipine and atorvastatin)
Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
Subjects who have taken any diets affecting absorption, metabolism, distribution and excretion of investigational products (especially grapefruit juice).
Subjects who are in conditions impossible participating in the clinical trials following other laboratory tests.
Unable to use contraceptions.
All locations for NCT03017950
Korea, Republic of (1)
Inha University Hospital
Incheon, Korea, Republic of
View full eligibility
Tris trial is registered with FDA with number: NCT03017950. The sponsor of the trial is Chong Kun Dang Pharmaceutical and it is looking for 83 volunteers for the current phase.
Official trial title: Phase I Clinical Trial to Evaluate the Pharmacokinetic Drug-drug Interaction of CKD-330 and D086 in Healthy Male Volunteers
1What's a trial
4Get in touch
What's a trial
Not sure you're well informed about clinical trials? Learn more about their benefits, risks and other important details.
Enter your details like condition, age, gender and other preferences and we will show you a list of all relevant clinical trials.
Review the summary of the selected clinical trial and all the locations near you in order to see if it's of interest to you.
Get in touch
You've found an interesting trial? We'll need a bit more information about you so we can connect you to the doctor in charge.
Some people want to consult their doctor before considering participation in a clinical trial. This is absolutely normal as your doctor should know your medical history and should be able to advise you. If you want you can easily share the information for this trial with your doctor by clicking on the button below.