Clinical trial NCT01341392: Drug-drug Interaction Study(CKD-501, Amlodipine)
Official title: A Randomized, Open-label, Multiple Dose, Three-treatment, Three-period, Six-sequence Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Amlodipine After Oral Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug-Drug interaction between the CKD-501 and Amlodipine
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Severance Hospital
First posted: 2011-04-25
Enrollment: 25
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501 and amlodipine after oral administration in healthy male volunteers.

Detailed description: Volunteers doses three times over the period of CKD-501 0.5mg or Amlodipine 10mg alone/co-administrate, repeated doses are 10 days.

Eligibility criteria: Inclusion Criteria:

* Between 20 aged and 45 years old in healthy males
* Body weight ≥ 55kg and 18.5 ≤ IBW \< 25
* Agreement with written informed consent

Exclusion Criteria:

* Subject has a history affects the ADME of drug
* Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party
* Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test)
* AST,ALT \> UNL \* 1.25 or Total bilirubin \> UNL \* 1.5
* Estimated GFR(MDRD) \< 80
* SBP \>150 mmHg, SBP \< 100 mmHg or DBP \> 100 mmHg, DBP \< 60 mmHg or Pulse \> 100 per/min, Pulse \< 50 per/min
* Substance abuse, or a history of drug abuse showed a positive for the party
* Continued to be taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials
* Medication with drug-mediated induction/inhibition metabolic enzyme within 30 days or with may affect the clinical trial
* Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking
* Subject takes grapefruit within 1 month
* Previously participated in other trial within 60 days
* Previously donate whole blood within 60 days or component blood within 30 days
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Primary outcomes:
measure: CKD-501 AUC
timeFrame: Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr
measure: Amlodipine AUC
timeFrame: Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr
Secondary outcomes:
measure: CKD-5011 Tmax
timeFrame: Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr
measure: Amlodipine Tmax
timeFrame: Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Minsoo Park
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim CO, Sil Oh E, Kim C, Park MS. Pharmacokinetic Interaction Between Amlodipine and Lobeglitazone, a Novel Peroxisome Proliferator-activated Receptor-gamma Agonist, in Healthy Subjects. Clin Ther. 2015 Sep;37(9):1999-2006.e1. doi: 10.1016/j.clinthera.2015.06.009. Epub 2015 Jul 7.