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CKD-828 (80/5mg) Pharmacokinetic Study

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ClinicalTrials.gov Identifier: NCT02250833
Recruitment Status : Completed
First Posted : September 26, 2014
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Study Description
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Brief Summary:
A randomized, open-label, single-dose, two-period, two-way, crossover study to compare the pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration telmisartan and s-amlodipine in health volunteers.

Condition or disease Intervention/treatment Phase
Hypertension Drug: CKD-828 Drug: Telmisartan Drug: S-amlodipine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Compare the Pharmacokinetics and Safety of CKD-828 80/5mg to Coadministration of Telmisartan 80mg and S-amlodipine 5mg in Healthy Male Volunteers
Study Start Date : September 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CKD-828(Fixed Dose Combination)
FDC tablet consisting of Telmisartan 80mg/S-Amlodipine 5mg
 Drug: CKD-828
Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily
Other Name: Telminuvo
Active Comparator: Combination Therapy
Coadministration of Telmisartan 80mg and S-amlodipine 5mg
 Drug: Telmisartan
- Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine)
Other Name: Micardis

Drug: S-amlodipine
- S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan)
Other Name: Anydipine s


Outcome Measures
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Primary Outcome Measures :
  1. Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. [ Time Frame: up to 168 hours post dose ]
  2. AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. [ Time Frame: up to 168 hours post dose ]

Secondary Outcome Measures :
  1. Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. [ Time Frame: up to 168 hours post dose ]
  2. t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. [ Time Frame: up to 168 hours post dose ]
  3. AUCinf after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. [ Time Frame: up to 168 hours post dose ]
  4. Number of participants with adverse events [ Time Frame: up to 31days post dose ]
    • Adverse Event monitoring
    • Evaluated safety parameters included: Physical examination, Vital sign, ECG, laboratory test


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A healthy volunteer between 20 and 55 years old
  • More than 50kg and within 20% of ideal body weight
  • No any congenital or chronic diseases and medical symptom
  • Appropriate for the study from examination(laboratory test, ECG etc.) within 4weeks prior to the first IP administration
  • Signed the informed consent form prior to the study participation.

Exclusion Criteria:

  • History of relevant hypersensitivity against drug
  • Clinical significant disease or medical history (ex. hepato/cholangio, cardio, endo, hemato, onco, CNS etc.)
  • Active liver disease or abnormal laboratory result (AST or ALT or Total bilirubin > 1.5*ULN)
  • SBP <90mmHg or SBP >150mmHg
  • DBP <50mmHg or DBP >100mmHg
  • Creatinine clearance <80mL/min
  • A Disease(ex.inflammatory intestinal disease, gastric or duodenal ulcer ,hepatic disease history , gastro-intestinal surgery except for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug
  • The evidence of severe attack or acute disease or surgical intervention within 28 days prior to the first IP administration.
  • A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or regular alcohol consumer(more than 21 units/week) or a heavy smoker(more than 10 cigarettes per a day)
  • Taking ETC medicine or oriental medicine within 14days or Taking OTC medicine within 7days prior to the first IP administration
  • Abnormal diet(Especially, grapefruit juice within 7 days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02250833


Locations
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Korea, Republic of
Kyungpook National University Hospital
Daegu, samdeok-dong, 2-ga 50, samdeok-dong, 2-ga 50 Jung-gu, Korea, Republic of, 700-721
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Young-Ran Yoon Kyungpook National University Hospital Clinical Trial Center
More Information
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02250833    
Other Study ID Numbers: 130HPS14006
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015
Keywords provided by Chong Kun Dang Pharmaceutical:
Hypertension
CKD-828
Telmisartan
S-amlodipine
Pharmacokinetic
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Antihypertensive Agents
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists