Status and phase
Conditions
Treatments
About
A randomized, open-label, fed, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 in healthy volunteers
Full description
To healthy subjects of 52, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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.)
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
Subject who shows the following values as a result of laboratory tests
*ALT or AST > 2 times upper limit of normal range
Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months of screening
Subject who smokes more than one pack of cigarette a day within 6 months of screening
Subject who took other clinical trial drugs or bioequivalence test drugs within 3 months before the first administration of clinical trial drug
Subject who conform to the specific items below
Subject who has significant alcohol abuse or drug abuse within a year of screening
Subject who took drugs which are known as disturbing drug metabolism within 30 days prior to the first administration of clinical trial drug.
Subject who uses any of other drugs, including over-the-counter medications and prescription medications within 10 days prior to first administration of clinical trial drug.
Subject who donated whole blood within 2 months prior to first administration of clinical trial drug or blood components within 1 month prior to first administration of clinical trial drug
Subject who is hypersensitive to the components of a clinical trial drug or clinical trial drug itself.
Subject who does not consent to reliable contraception during the entire period of clinical trial and until 7th day of administration of clinical trial drug.
Subject who is not able to consume high-fat meal provided during the clinical trial
Any other subject who is decided by investigators to be ineligible in clinical trial
Primary purpose
Allocation
Interventional model
Masking
52 participants in 2 patient groups
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Central trial contact
Min-Gul Kim; Kyung-Ho Jang
Data sourced from clinicaltrials.gov
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