CKD-828(80/2.5mg) Pharmacokinetic Study_2nd

NCT01352689 | Completed Phase 1

• 1 other identifier: 130HPS11K
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Keywords

CKD-828; Hypertension; Primary Hypertension; Healthy Volunteer; S-Amlodipine; Telmisartan; Amlodipine; Pharmacokinetic; Phase 1

Outcome Measures

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.

  up to 168 hous postdose

Secondary Outcomes (2)

• 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

Study Arms (2)

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)

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

Drug: Combination Therapy

Interventions

CKD-828(FDC) DRUG

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

CKD-828(Fixed Dose Combination)

Combination Therapy DRUG

Drug: Telmisatan 80mg Tablet, Oral, Once Daily Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily

Free combination Therapy

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 12, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 8, 2011

Record last verified: 2011-04