CKD-828(80/2.5mg) Pharmacokinetic Study

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: NCT01246193
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : January 19, 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 : 65 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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 : November 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Amlodipine
U.S. FDA Resources

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
Active Comparator: 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 hours postdose ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

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:   All
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.
  • The evidence of acute disease within 28 days prior to the first IP administraion.
  • 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 or DBP<50mmHg.
  • Abnormal laboratory result(s): AST or ALT > 1.25 times of upper limit / Total bilirubin > 1.5 times of upper limit.
  • A drug abuse or 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.
  • Diet(Especially, grapefruit juice-within 7 days prior to the first IP administraion) that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
  • Donated whole blood within 60 days prior to the first IP administraion.
  • Participated in the other clinical trials within 90days prior to the first IP administraion.
  • Medicine within 10 days prior to the first IP administraion? Does the medication affect this trial.
  • A pregnant or nursing women who does not use medically acceptable birth control.
  • Appropriate for the trial judging from principal investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01246193

Korea, Republic of
Inje Unuversity Pusan Paik Hospital
Pusan, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Principal Investigator: Eunyoung Kim Inje Unuversity Pusan Paik Hospital

Responsible Party: Jin Kim / Director, Clincal Research Department Identifier: NCT01246193     History of Changes
Other Study ID Numbers: 130HPS10C
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 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