Clinical trial NCT01352689: CKD-828(80/2.5mg) Pharmacokinetic Study_2nd
Official title: Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Telmisatan 80mg and S-Amlodipine 2.5mg as a Fixed Dose Combination Tablet Compared With Combination Therapy in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: CKD-828
Hypertension
Primary Hypertension
Healthy Volunteer
S-Amlodipine
Telmisartan
Amlodipine
Pharmacokinetic
Phase 1
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-05-12
Enrollment: 67
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.


Eligibility criteria: Inclusion Criteria:

* A healthy volunteer between 20 and 55 years old with body weight within 20% of ideal body weight.
* Have not any congenital or chronic diseases and medical symptom.
* Appropriate for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening).
* Able to participate in the entire trial.
* Signed the informed consent form prior to the study participation.

Exclusion Criteria:

* Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administraion.
* Take oriental medicine inside St John's Wort or metabolism of CYP3A4 enzyme or inhibite the CYP enzyme or increase the making drugs(itraconazole, ketoconazole, erythromycine, clarithromycine, telithromycin, HIV protease inhibitor)
* Disease(ex: imflammatory intestinal disease, gastric or duodenal ulcer ,hepatic diseasehistory , gastro intestinal surgery exept for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
* Relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication.
* Hypersensitivity Telmisartan or Amlodipine.
* SBP\<90mmHg, 150mmHg\<SBP or DBP\<50mmHg, 100mmHg\<DBP.
* Abnormal laboratory result(s): AST or ALT \> 1.25 times of upper limit / Total bilirubin \> 1.5 times of upper limit.
* Creatinine Clearance\<80mL/min
* Clinically significant cardiovascular system, pulmonary system, liver system, renal system, blood system, nervous system or hyperpotassemia (Past history or present)
* History of drug abuse(sleeping tablet, nucleus action painkiller, an opiate or psychotrope etc the central nervous system drug)or showed a positive for the urine screening exam.
* any abnormal diet which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. drinking grapefruit juice(more than 1L per a day) during 7 weeks prior to the first IP administration.)
* A heavy caffeine consumer (more than 5 cups per a day) or a heavy smoker(more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.
* Previously donate whole blood within 60 days or component blood within 30 days prior to the first IP administraion.
* Medication within 7 days in the first IP administraion professional medical, medicine, OTC taking
* Participated in the other clinical trials within 60days prior to the first IP administraion.
* An impossible one who participates in clinical trial by investigator's decision

Primary outcomes:
measure: The area under the plasma concentration-time curve (AUC) and Cmax after administration of CKD-828(Fixed Dose Combination) tablet and co-administration of corresponding dose of Telmisartan and S-Amlodipine as individual tablets.
timeFrame: up to 168 hous postdose
Secondary outcomes:
measure: Tmax and t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and co-administration of corresponding dose of Telmisartan and S-Amlodipine as individual tablets.
timeFrame: up to 168 hours postdose
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to 22days
Other outcomes:
Locations:
Study officials:
References: