Clinical trial NCT01340131: CKD-828 (40/5mg) Pharmacokinetic Study
Official title: Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Telmisatan 40mg and S-Amlodipine 5mg as a Fixed Dose Combination Tablet Compared With Combination Therapy in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: CKD-828
Hypertension
Primary Hypertension
Healthy Volunteer
S-Amlodipine
Telmisartan
Amlodipine
Pharmacokinetic
Phase 1
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-04-22
Enrollment: 68
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.
* Appropriate for the trial judging from principal investigator.

Primary outcomes:
measure: Cmax after administration of CKD-828(Fixed Dose Combination) tablet and co-administration of corresponding dose of Telmisartan and S-Amlodipine as individual tablets.
timeFrame: up to 168 hours postdose
measure: The area under the plasma concentration-time curve (AUC) after administration of CKD-828(Fixed Dose Combination) tablet and co-administration of corresponding dose of Telmisartan and S-Amlodipine as individual tablets.
timeFrame: up to 168 hours postdose
Secondary outcomes:
measure: 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.
timeFrame: up to 168 hours postdose
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to 22days
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
Study officials:
affiliation: Inje University
name: Eunyoung Kim
role: PRINCIPAL_INVESTIGATOR
References: