CKD-828(80/2.5mg) Pharmacokinetic Study_2nd
This study has been completed.
Information provided by:
Chong Kun Dang Pharmaceutical
First received: May 11, 2011
Last updated: June 6, 2011
Last verified: April 2011
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.
Drug: Combination Therapy
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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. [ Time Frame: up to 168 hous postdose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. [ Time Frame: up to 168 hours postdose ] [ Designated as safety issue: Yes ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to 22days ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2011 (Final data collection date for primary outcome measure)
Experimental: CKD-828(Fixed Dose Combination)
Single oral dose of a FDC tablet consisting of Telmisatan 80mg/S-Amlodipine 2.5mg
Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily
Experimental: Free combination Therapy
Co-administration of single oral doses of a 80mg tablet of Telmisatan and a 2.5 mg tablet of S-Amlodipine
Drug: Combination Therapy
Drug: Telmisatan 80mg Tablet, Oral, Once Daily
Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily
|Ages Eligible for Study:
||20 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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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No Contacts or Locations Provided
No publications provided
||Jin Kim / Director, Clincal Research Department
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 11, 2011
||June 6, 2011
||Korea: Food and Drug Administration
Keywords provided by Chong Kun Dang Pharmaceutical:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 23, 2014
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