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CompletedNCT02250833Updated Apr 10, 2015

CKD-828 (80/5mg) Pharmacokinetic Study

A Phase 1 interventional study of CKD-828 and Telmisartan in Hypertension, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in South Korea. Open to male participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-10.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
  • CKD-828
  • Telmisartan
  • S-amlodipine
  • Pharmacokinetic
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 69 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 299 studies on the registry; 15 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    CKD-828(Fixed Dose Combination)

    FDC tablet consisting of Telmisartan 80mg/S-Amlodipine 5mg

    Drug: CKD-828

  • Active comparator
    Combination Therapy

    Coadministration of Telmisartan 80mg and S-amlodipine 5mg

    Drug: Telmisartan · Drug: S-amlodipine

Interventions

  • DrugCKD-828

    Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily

    Also known as: Telminuvo

  • DrugTelmisartan

    \- Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine)

    Also known as: Micardis

  • DrugS-amlodipine

    \- S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan)

    Also known as: Anydipine s

06

What researchers measure

Primary outcomes

  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 outcomes

  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

    * Adverse Event monitoring * Evaluated safety parameters included: Physical examination, Vital sign, ECG, laboratory test

    Time frame: up to 31days post dose

07

Study locations

1 site
  • Kyungpook National University Hospital
    Daegu, Samdeok-dong, 2-ga 50, Samdeok-dong, 2-ga 50 Jung-gu 700-721, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02250833
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Sep 26, 2014
Start date
Sep 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Apr 10, 2015

Study contacts

Young-Ran Yoon
principal investigator · Kyungpook National University Hospital Clinical Trial Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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