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CKD-828 (80/5mg) Pharmacokinetic Study

Information source: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: CKD-828 (Drug); Telmisartan (Drug); S-amlodipine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Chong Kun Dang Pharmaceutical

Official(s) and/or principal investigator(s):
Young-Ran Yoon, Principal Investigator, Affiliation: Kyungpook National University Hospital Clinical Trial Center

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.

AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.

Secondary outcome:

Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.

t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.

AUCinf after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.

Number of participants with adverse events

Eligibility

Minimum age: 19 Years. Maximum age: 55 Years. Gender(s): Male.

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

Locations and Contacts

Kyungpook National University Hospital, Daegu, samdeok-dong, 2-ga 50, samdeok-dong, 2-ga 50 Jung-gu 700-721, Korea, Republic of
Additional Information

Starting date: September 2014
Last updated: April 8, 2015

Page last updated: August 23, 2015

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