CKD-828 Drug Interaction Study (Telmisartan) | NCT01356017

NCT01356017

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

Name	Class
Asan Medical Center	OTHER

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
Free combination of Telmisartan and S-amlodipine	Experimental	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
Telmisartan monotherapy	Active Comparator	Subjects received Telmisartan 80mg once a day for 9 days. And subjects doesn't take any medications for 19 days.	Drug: Telmisartan 80mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telmisartan 80mg, S-amlodipine 5mg	Drug	Telmisartan 80mg and S-amlodipine 5mg, Oral, Once a day, for 9 days + Wash out (19 days)	Free combination of Telmisartan and S-amlodipine

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

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

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Kyun S Bae, Ph.D.	Asan Medical Center	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22721873	Derived	Noh YH, Lim HS, Kim MJ, Kim YH, Choi HY, Sung HR, Jin SJ, Lim J, Bae KS. Pharmacokinetic interaction of telmisartan with s-amlodipine: an open-label, two-period crossover study in healthy Korean male volunteers. Clin Ther. 2012 Jul;34(7):1625-35. doi: 10.1016/j.clinthera.2012.05.010. Epub 2012 Jun 19.

ID	Term
D000077333	Telmisartan
C542574	levamlodipine

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic