NCT01352689CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 67
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
- •Take oriental medicine inside St John's Wort or metabolism of CYP3A4 enzyme or inhibite the CYP enzyme or increase the making drugs(itraconazole, ketoconazole, erythromycine, clarithromycine, telithromycin, HIV protease inhibitor)
- •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, 150mmHg<SBP or DBP<50mmHg, 100mmHg<DBP.
- •Abnormal laboratory result(s): AST or ALT > 1.25 times of upper limit / Total bilirubin > 1.5 times of upper limit.
- •Creatinine Clearance<80mL/min
- •Clinically significant cardiovascular system, pulmonary system, liver system, renal system, blood system, nervous system or hyperpotassemia (Past history or present)
- •History of drug abuse(sleeping tablet, nucleus action painkiller, an opiate or psychotrope etc the central nervous system drug)or showed a positive for the urine screening exam.
- •any abnormal diet which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. drinking grapefruit juice(more than 1L per a day) during 7 weeks prior to the first IP administration.)
- •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.
- •Previously donate whole blood within 60 days or component blood within 30 days prior to the first IP administraion.
- •Medication within 7 days in the first IP administraion professional medical, medicine, OTC taking
- •Participated in the other clinical trials within 60days prior to the first IP administraion.
- •An impossible one who participates in clinical trial by investigator's decision
Arms & Interventions
CKD-828(Fixed Dose Combination)
Experimental
Single oral dose of a FDC tablet consisting of Telmisatan 80mg/S-Amlodipine 2.5mg
Intervention: CKD-828(FDC) (Drug)
Free combination Therapy
Experimental
Co-administration of single oral doses of a 80mg tablet of Telmisatan and a 2.5 mg tablet of S-Amlodipine
Intervention: Combination Therapy (Drug)
Outcomes
Primary Outcomes
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 hous postdose
Secondary Outcomes
- Tmax and t1/2 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)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(up to 22days)
Investigators
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