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Completed

NCT Number: NCT01341392

Drug-drug Interaction Study(CKD-501, Amlodipine)

The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501 and amlodipine after oral administration in healthy male volunteers.

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Key information

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital

Seoul, 120-752, South Korea

About this study

Volunteers doses three times over the period of CKD-501 0.5mg or Amlodipine 10mg alone/co-administrate, repeated doses are 10 days.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 20 aged and 45 years old in healthy males
  • Body weight ≥ 55kg and 18.5 ≤ IBW < 25
  • Agreement with written informed consent

Exclusion criteria

  • Subject has a history affects the ADME of drug
  • Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party
  • Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test)
  • AST,ALT > UNL * 1.25 or Total bilirubin > UNL * 1.5
  • Estimated GFR(MDRD) < 80
  • SBP >150 mmHg, SBP < 100 mmHg or DBP > 100 mmHg, DBP < 60 mmHg or Pulse > 100 per/min, Pulse < 50 per/min
  • Substance abuse, or a history of drug abuse showed a positive for the party
  • Continued to be taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
  • Medication with drug-mediated induction/inhibition metabolic enzyme within 30 days or with may affect the clinical trial
  • Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking
  • Subject takes grapefruit within 1 month
  • Previously participated in other trial within 60 days
  • Previously donate whole blood within 60 days or component blood within 30 days
  • An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Treatment and study plan

CKD-501

Drug

Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.

Other names: Lobeglitazone

amlodiopine

Drug

Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.

CKD-501 amlodipine

Drug

Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.

Primary outcomes

  1. CKD-501 AUC

    Time frame: Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr

  2. Amlodipine AUC

    Time frame: Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr

Secondary outcomes

  1. CKD-5011 Tmax

    Time frame: Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr

  2. Amlodipine Tmax

    Time frame: Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Collaborators

  • Severance Hospital

Registry information

Official study title

A Randomized, Open-label, Multiple Dose, Three-treatment, Three-period, Six-sequence Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Amlodipine After Oral Administration in Healthy Male Volunteers

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 25, 2011
Registry last updated
Aug 15, 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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