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

Unknown statusPhase 1NCT03748212
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
A Randomized, Open-label, Fed, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 in Healthy Volunteers
Conditions
Interventions
  • Drug: D935 Cap. 1T
  • Drug: CKD-385 Tab. 1T
Sponsor
Chong Kun Dang Pharmaceutical
Start date
2018-10-24
Primary completion
2018-12
Sex
All
Age range
from 19 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
South Korea
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 no medical symptoms or signs as a result of medical examination 4. Suitable subject who is determined at the time of screening by examiners according to the 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 University Hospital IRB to participate in this study with full understanding of the purpose and contents 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 Criteria: 1. Subject who has (or has histories of) clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological or allergic diseases(except for asymptomatic seasonal allergy at the time of administration) 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 esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug 3. Subject who shows the following values as a result of laboratory tests \*ALT or AST \> 2 times upper limit of normal range 4. Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months of screening 5. Subject who smokes more than one pack of cigarette a day within 6 months of screening 6. Subject who took other clinical trial drugs or bioequivalence test drugs within 3 months before the first administration of clinical trial drug 7. Subject who conform to the specific items below * systolic blood pressure less than 90 mmHg, greater than 140 mmHg or diastolic blood pressure less than 60 mmHg or greater than 90 mmHg in a sitting position * Severe bradycardia (less than 50 beats/minute) 8. Subject who has significant alcohol abuse or drug abuse within a year of screening 9. Subject who took drugs which are known as disturbing drug metabolism within 30 days prior to the first administration of clinical trial drug. 10. Subject …

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03748212