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CKD-828(80/2.5mg) Pharmacokinetic Study

This study has been completed.
Information provided by:
Chong Kun Dang Pharmaceutical Identifier:
First received: November 17, 2010
Last updated: January 17, 2011
Last verified: January 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.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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 hours postdose ]

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

Enrollment: 65
Study Start Date: November 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (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
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


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.
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Jin Kim / Director, Clincal Research Department Identifier: NCT01246193     History of Changes
Other Study ID Numbers: 130HPS10C
Study First Received: November 17, 2010
Last Updated: January 17, 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 processed this record on September 19, 2017