We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CKD-828 Drug Interaction Study (Telmisartan)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01356017
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : September 7, 2011
Sponsor:
Collaborator:
Asan Medical Center
Information provided by:
Chong Kun Dang Pharmaceutical

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Healthy Male Volunteers Drug: Telmisartan 80mg, S-amlodipine 5mg Drug: Telmisartan 80mg Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Telmisartan AUC [ Time Frame: 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr ]

Secondary Outcome Measures :
  1. Telmisartan Cmax [ Time Frame: 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr ]
  2. Telmisartan Tmax [ Time Frame: 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356017


Locations
Layout table for location information
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Asan Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Kyun S Bae, Ph.D. Asan Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Jin Kim/ Director, Clinical Research Department
ClinicalTrials.gov Identifier: NCT01356017    
Other Study ID Numbers: 130HPS11C
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Amlodipine
Telmisartan
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists