CKD-828(80/2.5mg) Pharmacokinetic Study_2nd

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: CKD-828(FDC); Drug: Combination Therapy

• Registration Number: NCT01352689
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study Start: 2011-04
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-05-11
• Study First Submitted QC: 2011-05-11
• Study First Posted: 2011-05-12
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 67

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CKD-828(Fixed Dose Combination)	CKD-828(FDC)	Single oral dose of a FDC tablet consisting of Telmisatan 80mg/S-Amlodipine 2.5mg
Free combination Therapy	Combination Therapy	Co-administration of single oral doses of a 80mg tablet of Telmisatan and a 2.5 mg tablet of S-Amlodipine

Primary Outcome Measures

Name	Time	Method
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.	up to 168 hous postdose

Secondary Outcome Measures

Name	Time	Method
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.	up to 168 hours postdose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	up to 22days