CKD-828(80/2.5mg) Pharmacokinetic Study_2nd

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01352689
Recruitment Status : Completed
First Posted : May 12, 2011
Last Update Posted : June 8, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: CKD-828(FDC) Drug: Combination Therapy Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : April 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Amlodipine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to 22days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Jin Kim / Director, Clincal Research Department Identifier: NCT01352689     History of Changes
Other Study ID Numbers: 130HPS11K
First Posted: May 12, 2011    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: April 2011

Keywords provided by Chong Kun Dang Pharmaceutical:
Primary Hypertension
Healthy Volunteer
Phase 1

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists