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Completed

NCT Number: NCT01356043

CKD-828 Drug Interaction Study (S-amlodipine)

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.

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Key information

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S-amlodipine 5mg,Telmisartan 80mg

Drug

S-amlodipine 5mg and Telmisartan 80mg, Oral, Once a day, for 9 days + Wash out (19 days)

Other names: Anydipine S 5mg, Micardis 80mg

S-amlodipine 5mg

Drug

S-amlodipine 5mg, Oral, Once a day, for 9 days + Wash out(19 days)

Other names: Anydipine S 5mg

Primary outcomes

  1. S-amlodipine AUC

    Time frame: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr

Secondary outcomes

  1. S-amlodipine Cmax

    Time frame: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr

  2. S-amlodipine Tmax

    Time frame: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Collaborators

  • Asan Medical Center

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 19, 2011
Registry last updated
Aug 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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