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Completed

NCT Number: NCT02250833

CKD-828 (80/5mg) Pharmacokinetic Study

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.

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Key information

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook National University Hospital

Daegu, Samdeok-dong, 2-ga 50, Samdeok-dong, 2-ga 50 Jung-gu, 700-721, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CKD-828

Drug

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

Other names: Telminuvo

Telmisartan

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

Other names: Micardis

S-amlodipine

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

Other names: Anydipine s

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

    Time frame: up to 31days post dose

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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 26, 2014
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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