CKD-828 Drug Interaction Study (Telmisartan)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of Telmisartan between free combination of Telmisartan and S-amlodipine and Telmisartan monotherapy.

Official Title
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A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety of Telmisartan Between Free Combination of Telmisartan and S-amlodipine and Telmisartan Monotherapy in Healthy Male Volunteers

Conditions
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Healthy Male Volunteers

Intervention / Treatment
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* Drug: Telmisartan 80mg, S-amlodipine 5mg
* Drug: Telmisartan 80mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 20 aged and 50 aged in healthy males Weight more than 55kg, BMI 19kg/m2-26kg/m2 at the period of screening 100mmHg ≤ sit SBP < 140mmHg and 60mmHg ≤ sit DBP < 90mmHg and 50 per/min ≤ Pulse rate < 95 per/min AST, ALT, Total bilirubin < UNL x 1.5 Signed the informed consent from prior to the study participation Exclusion Criteria: Have history of significant hepatic, renal, gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, hernia repair) affected by the absorption of medications galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of telmisartan or Amlodipine drug abuse, or have a history of drug abuse showed a positive for the Triage TOX drug on urine : amphetamine, barbiturate, cocaine, opiates, benzodiazepines, THC(cannabinoids), methadone etc. Subject takes herbal medicine within 30 days, ethical drug within 14 days, OTC within 7 days before the beginning of study treatment unusual diet affected by the absorption, distribution, metabolism, excretion of medications Subject who treated with any investigational drugs within 90 days before the beginning of study treatment Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days A heavy caffeine consumer (caffeine > 5 units/day), A heavy alcohol consumer (alcohol > 21 units/week, 1 unit=pure alcohol 10mL) or cannot stop drinking A heavy smoker (cigarette > 20 cigarettes per day) Positive for Hepatitis B, Hepatitis C, HIV or syphilis An impossible one who participates in clinical trial by investigator's decision including laboratory test result, EKG result

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Free combination of Telmisartan and S-amlodipine<br>Subjects received Telmisartan 80mg and S-amlodipine 5mg once a day for 9 days. And subjects doesn't take any medications for 19 days. | Drug: Telmisartan 80mg, S-amlodipine 5mg<br>* Telmisartan 80mg and S-amlodipine 5mg, Oral, Once a day, for 9 days + Wash out (19 days)<br>* Other names: Micardis 80mg, Anydipine S 5mg;|
| Active Comparator: Telmisartan monotherapy<br>Subjects received Telmisartan 80mg once a day for 9 days. And subjects doesn't take any medications for 19 days. | Drug: Telmisartan 80mg<br>* Telmisartan 80mg, Oral, Once a day, for 9 days + Wash out (19 days)<br>* Other names: Micardis 80mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telmisartan AUC |  | 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telmisartan Cmax |  | 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr | 
| Telmisartan Tmax |  | 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr |