CKD-828(80/2.5mg) Pharmacokinetic Study_2nd - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: CKD-828(FDC) Drug: Combination Therapy	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate

U.S. FDA Resources

Further study details as provided by Chong Kun Dang Pharmaceutical:

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 ]

Enrollment:	67
Study Start Date:	April 2011
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CKD-828(Fixed Dose Combination) Single oral dose of a FDC tablet consisting of Telmisatan 80mg/S-Amlodipine 2.5mg	Drug: CKD-828(FDC) 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

Eligibility

Ages Eligible for Study:	20 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Jin Kim / Director, Clincal Research Department
ClinicalTrials.gov Identifier:	NCT01352689 History of Changes
Other Study ID Numbers:	130HPS11K
Study First Received:	May 11, 2011
Last Updated:	June 6, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:

CKD-828
Hypertension
Primary Hypertension
Healthy Volunteer
S-Amlodipine

Telmisartan
Amlodipine
Pharmacokinetic
Phase 1

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 16, 2013