CKD-828 Drug Interaction Study (S-amlodipine)

This study has been completed.
Sponsor:
Collaborator:
Asan Medical Center
Information provided by:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01356043
First received: May 17, 2011
Last updated: August 29, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Healthy Male Volunteers
Drug: S-amlodipine 5mg,Telmisartan 80mg
Drug: S-amlodipine 5mg
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 the Pharmacokinetic Drug Interaction and Safety of S-amlodipine Between Free Combination of S-amlodipine and Telmisartan and S-amlodipine Monotherapy in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • S-amlodipine AUC [ Time Frame: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • S-amlodipine Cmax [ Time Frame: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr ] [ Designated as safety issue: No ]
  • S-amlodipine Tmax [ Time Frame: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Free combination of S-amlodipine and Telmisartan
Subjects received S-amlodipine 5mg and Telmisartan 80mg once a day for 9 days. And subjects doesn't take any medications for 19 days.
Drug: S-amlodipine 5mg,Telmisartan 80mg
S-amlodipine 5mg and Telmisartan 80mg, Oral, Once a day, for 9 days + Wash out (19 days)
Other Name: Anydipine S 5mg, Micardis 80mg
Active Comparator: S-amlodipine monotherapy
Subjects received S-amlodipine 5mg once a day for 9 days. And subjects doesn't take any medications for 19 days.
Drug: S-amlodipine 5mg
S-amlodipine 5mg, Oral, Once a day, for 9 days + Wash out(19 days)
Other Name: Anydipine S 5mg

  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 who 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356043

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: NCT01356043     History of Changes
Other Study ID Numbers: 130HPS11D
Study First Received: May 17, 2011
Last Updated: August 29, 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 April 22, 2014