Clinical Trial to Evaluate Pharmacokinetic Profiles and Safety Between CKD-385 and D935 in Healthy Volunteers

Last updated: December 27, 2018
Sponsor: Chong Kun Dang Pharmaceutical
Overall Status: Active - Recruiting

Phase

1

Condition

Stress

Vascular Diseases

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT03748212
188BE18024
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

A randomized, open-label, fed, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 in healthy volunteers

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. A healthy adult aged over 19 at the time of screening

  2. Weight over 55, with BMI between 17.5kg/m² and 30.5kg/m²

  3. Subject who has no congenital or chronic disease within the last 3 years and nomedical symptoms or signs as a result of medical examination

  4. Suitable subject who is determined at the time of screening by examiners according tothe characteristics of the medicine such as hematology test, blood chemistry test,urine test, virus / bacteriological test, vital signs, electrocardiogram test

  5. Subject who signed the written consent form approved by Chonbuk National UniversityHospital IRB to participate in this study with full understanding of the purpose andcontents of the examination prior to participation of the clinical trial

  6. Subject who has the ability and willingness to participate in the clinical trial

Exclusion

Exclusion Criteria:

  1. Subject who has (or has histories of) clinically significant blood, kidney, endocrine,respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological orallergic diseases(except for asymptomatic seasonal allergy at the time ofadministration) or evidence(except for simple dental history such as dental calculus,impacted tooth, wisdom tooth, etc.)

  2. Subject with a history of gastrointestinal disorders(esophageal achalasia or esophagusstenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitissurgery or hernia surgery or tooth extraction surgery) that may affect the absorptionof drug

  3. Subject who shows the following values as a result of laboratory tests

*ALT or AST > 2 times upper limit of normal range

  1. Subject who has a history of regular alcohol consumption in excess of 210 g/weekwithin 6 months of screening

  2. Subject who smokes more than one pack of cigarette a day within 6 months of screening

  3. Subject who took other clinical trial drugs or bioequivalence test drugs within 3months before the first administration of clinical trial drug

  4. Subject who conform to the specific items below

  • systolic blood pressure less than 90 mmHg, greater than 140 mmHg or diastolicblood pressure less than 60 mmHg or greater than 90 mmHg in a sitting position

  • Severe bradycardia (less than 50 beats/minute)

  1. Subject who has significant alcohol abuse or drug abuse within a year of screening

  2. Subject who took drugs which are known as disturbing drug metabolism within 30 daysprior to the first administration of clinical trial drug.

  3. Subject who uses any of other drugs, including over-the-counter medications andprescription medications within 10 days prior to first administration of clinicaltrial drug.

  4. Subject who donated whole blood within 2 months prior to first administration ofclinical trial drug or blood components within 1 month prior to first administrationof clinical trial drug

  5. Subject who is hypersensitive to the components of a clinical trial drug or clinicaltrial drug itself.

  6. Subject who does not consent to reliable contraception during the entire period ofclinical trial and until 7th day of administration of clinical trial drug.

  7. Subject who is not able to consume high-fat meal provided during the clinical trial

  8. Any other subject who is decided by investigators to be ineligible in clinical trial

Study Design

Total Participants: 52
Study Start date:
October 24, 2018
Estimated Completion Date:
December 31, 2018

Study Description

To healthy subjects of 52, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

Connect with a study center

  • Chonbuk National University Hospital

    Jeonju,
    Korea, Republic of

    Active - Recruiting

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