Skip to main content
OpenTrials
Completed

NCT Number: NCT01246193

CKD-828(80/2.5mg) Pharmacokinetic Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inje Unuversity Pusan Paik Hospital

Pusan, 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 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.

Treatment and study plan

CKD-828(FDC)

Drug

Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily

Combination therapy

Drug

Drug: Telmisatan 80mg Tablet, Oral, Once Daily

Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily

Primary outcomes

  1. 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 outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 23, 2010
Registry last updated
Jan 19, 2011

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.

Published trials that share one or more normalized conditions with this study.