Status and phase
Conditions
Treatments
About
This study is a randomized, open, single-dose, 3 period partial replicated crossover-design study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers.
Full description
To healthy subjects of fifty-one (51), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Healthy adults over the age of 19 years and under the age of 55 years at the time of screening
Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg
* BMI = Weight(kg)/ Height(m)2
Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed at screening
Individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation
Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
Individuals with the ability and willingness to participate the entire study period
Exclusion criteria
Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
Individuals with the following results at screening test:
A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml) prior to screening or individuals who cannot quit drinking from 48hr prior to the first dose to end of last blooding (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening or cannot quit smoking during hospitalization period
Individuals who had been administered investigational product(s) of other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
Following vital signs results at screening
Individuals with a medical history of significant drug abuse within one year prior to the screening or positive for abuse drug in urine test results at screening
Individuals taking medication known to significantly induce or inhibit drug metabolizing enzymes within 30days before the first administration of clinical trial drug
Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
Individuals who donated whole blood within the 2 months, or blood components within 1 month prior to the first dose of the investigational product(s)
Individuals with hypersensitivity to investigational products or the investigational products ingredients
Patients or conditions deemed to be at risk for using investigational products
Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
Individuals who drunk grapefruit juice or caffeine more than 5 cup per day within 3 months prior to screening or cannot quit drinking during clinical trials period
Individuals who cannot eat standard meal in institution
Women who are pregnant or may be pregnant
Individuals who were deemed to be inappropriate to participate in the study by the investigator
Primary purpose
Allocation
Interventional model
Masking
51 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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