CKD-828 Drug Interaction Study (Telmisartan)

This study has been completed.
Sponsor:
Collaborator:
Asan Medical Center
Information provided by:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01356017
First received: May 17, 2011
Last updated: September 4, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Healthy Male Volunteers
Drug: Telmisartan 80mg, S-amlodipine 5mg
Drug: Telmisartan 80mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Telmisartan AUC [ Time Frame: 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Telmisartan Cmax [ Time Frame: 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr ] [ Designated as safety issue: No ]
  • Telmisartan Tmax [ Time Frame: 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356017

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Asan Medical Center
Investigators
Principal Investigator: Kyun S Bae, Ph.D. Asan Medical Center
  More Information

No publications provided by Chong Kun Dang Pharmaceutical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jin Kim/ Director, Clinical Research Department
ClinicalTrials.gov Identifier: NCT01356017     History of Changes
Other Study ID Numbers: 130HPS11C
Study First Received: May 17, 2011
Last Updated: September 4, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Amlodipine
Telmisartan
Benzoates
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 29, 2014