CKD-828(80/2.5mg) Pharmacokinetic Study | NCT01246193

NCT01246193

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CKD-828(Fixed Dose Combination)	Experimental	Single oral dose of a FDC tablet consisting of Telmisatan 80mg/S-Amlodipine 2.5mg	Drug: CKD-828(FDC)
Combination Therapy	Active Comparator	Co-administration of single oral doses of a 80mg tablet of Telmisatan and a 2.5 mg tablet of S-Amlodipine	Drug: Combination Therapy

Name	Type	Description	Arm Group Labels	Other Names
CKD-828(FDC)	Drug	Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily	CKD-828(Fixed Dose Combination)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		up to 168 hours postdose

Measure	Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Eligibility Module

Eligibility Criteria

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.

ID	Term
D006973	Hypertension
D000075222	Essential Hypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases