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CKD-828 (40/5mg) Pharmacokinetic Study

This study has been completed.
Sponsor:
Information provided by:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01340131
First received: March 30, 2011
Last updated: April 27, 2011
Last verified: April 2011
History of Changes
  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
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 40mg and S-Amlodipine 5mg as a Fixed Dose Combination Tablet Compared With Combination Therapy in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The area under the plasma concentration-time curve (AUC) 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: 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: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to 22days ] [ Designated as safety issue: Yes ]

Enrollment: 68
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: March 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 40mg/S-Amlodipine 5mg Intervention
 Drug: CKD-828
Drug: Telmisartan 40mg + S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily
Active Comparator: Free combination Therapy
Co-administration of single oral doses of a 40mg tablet of Telmisatan and a 5 mg tablet of S-Amlodipine
 Drug: Combination Therapy

Drug: Telmisartan 40mg Tablet, Oral, Once Daily

Drug: S-amlodipine 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.
  • 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.
  • Appropriate for the trial judging from principal investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340131

Locations
Korea, Republic of
Inje University Pusan Paik Hospital
Pusan, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Eunyoung Kim Inje University
  More Information

No publications provided

Responsible Party: Jin Kim / Director, Clinical Research Department
ClinicalTrials.gov Identifier: NCT01340131     History of Changes
Other Study ID Numbers: 130HPS10G
Study First Received: March 30, 2011
Last Updated: April 27, 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
Telmisartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013