Clinical trial NCT01356017: CKD-828 Drug Interaction Study (Telmisartan)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Asan Medical Center
First posted: 2011-05-19
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
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 drug interaction and safety of Telmisartan between free combination of Telmisartan and S-amlodipine and Telmisartan monotherapy.


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

Primary outcomes:
measure: Telmisartan AUC
timeFrame: 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr
Secondary outcomes:
measure: Telmisartan Cmax
timeFrame: 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr
measure: Telmisartan Tmax
timeFrame: 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun S Bae, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.