- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02250833
CKD-828 (80/5mg) Pharmacokinetic Study
April 8, 2015 updated by: Chong Kun Dang Pharmaceutical
To Compare the Pharmacokinetics and Safety of CKD-828 80/5mg to Coadministration of Telmisartan 80mg and S-amlodipine 5mg in Healthy Male Volunteers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
samdeok-dong, 2-ga 50 Jung-gu
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Daegu, samdeok-dong, 2-ga 50, samdeok-dong, 2-ga 50 Jung-gu, Korea, Republic of, 700-721
- Kyungpook National University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CKD-828(Fixed Dose Combination)
FDC tablet consisting of Telmisartan 80mg/S-Amlodipine 5mg
|
Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily
Other Names:
|
Active Comparator: Combination Therapy
Coadministration of Telmisartan 80mg and S-amlodipine 5mg
|
- Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine)
Other Names:
- S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
up to 168 hours post dose
|
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
|
up to 168 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 168 hours post dose
|
|
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
|
up to 168 hours post dose
|
|
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
|
up to 168 hours post dose
|
|
Number of participants with adverse events
Time Frame: up to 31days post dose
|
|
up to 31days post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
September 22, 2014
First Submitted That Met QC Criteria
September 24, 2014
First Posted (Estimate)
September 26, 2014
Study Record Updates
Last Update Posted (Estimate)
April 10, 2015
Last Update Submitted That Met QC Criteria
April 8, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Telmisartan
Other Study ID Numbers
- 130HPS14006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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