CKD-371: Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects
Study Details
Study Description
Brief Summary
This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
To healthy 32 subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: D745, D759 / Test drug: CKD-371
Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequence 1 Period 1 - A single dose of 2 tablets(D745, D759) under fasting condition. Period 2 - A single dose of 1 tablets(CKD-371) under fasting condition. |
Drug: CKD-371
PO
Other Names:
|
| Experimental: Sequence 2 Period 1 - A single dose of 1 tablets(CKD-371) under fasting condition. Period 2 - A single dose of 2 tablets(D745, D759) under fasting condition. |
Drug: CKD-371
PO
Other Names:
|
Outcome Measures
Primary Outcome Measures
- AUCt of CKD-371, D745+D759 [Pre-dose(0hr), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48hr]
Area under the CKD-371, D745+D759 concentration in blood-time curve from zero to final
- Cmax of CKD-371, D745+D759 [Pre-dose(0hr), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48hr]
The maximum CKD-388/D418 concentration in blood sampling time
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy adults volunteers aged between 19 and 45 years old at the time of screening
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Weight ≥50kg, with calculated body mass index (BMI) of 18.0 to 29.9 kg/m2 at the time of screening
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Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial
Exclusion Criteria:
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Those with clinically significant diseases or history in cardiovascular system, respiratory system, liver, kidney, hematological, gastrointestinal, endocrine system, immune system, skin system, mental/nervous system, etc
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Those who have symptoms of acute disease within 28 days of the the first dose of the investigational product
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Those who with a history of influencing drug absorption, distribution, metabolism, and excretion
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Those who have a hypersensitivity reaction or a history of clinically significant hypersensitivity reaction or a history of drug abuse inculding SGLT2 inhibitor class component or DPP 4 inhibitor class or same class component drugs containing ingredients
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Those with clinically significant active chronic disease
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Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption
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A person who has had one or more of the following results in screening tests including re-examination
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AST, ALT > UNL (upper normal limit) x 2.5
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Fasting glucose < 70 mg/dL
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Calculated by Cockcroft Gault formula Creatinine clearance is 75mL/min or less (Cockcroft Gault GFR = (140 age) * (Wt in kg) / (72 * Cr))
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QTc > 470 msec as a result of ECG
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Urine-hCG test is positive(if it is limited to female subjects)
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Those who test positive for HBs Ag, HCV Ab, HIV Ab, or VDRL
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Those who have taken prescription medicine (ETCs), including prescription drugs, within 14 days of the first dose
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Those who have taken over-the-counter medicines (OTC) including herbal medicines within 7 days of the first dose
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Clinically significant allergic diseases, mild allergic rhinitis that do not require medication, and allergic dermatitis can be selected
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Those who cannot eat the standard meal provided by the institution
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Those who donated whole blood within 60 days prior to the first dose or donated component blood within 20 days
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Those who received a blood transfusion within 30 days prior to the first dose
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Those who have participated in other clinical studies or bioequivalence studies within 6 months of the first dose and administered the investigational drug
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Those who had taken any drug known as a strong inducer or inhibitor of drug-metabolizing enzymes within 30 days prior to the first dose of the investigational product
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Those who have continuously consumed grapefruit juice or caffeine > 5 cups a day, or cannot refrain from intake during hospitalization
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Consistently drinking alcohol > 30 days or unable to abstain from alcohol during hospitalization
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Excessive smokers > 20 cigarettes non-daily or unable to quit smoking during hospitalization
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Pregnant or childbearing potential and lactating women
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Those who consent to the use of reliable contraception(contraceptive methods other than hormones: use of condoms, intrauterine devices (IUD, IUS), tubal ligation, cervical cap, contraceptive diaphragm, etc.) during the clinical trial and not to donate sperm until 2 month after the last administration of investigational product
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Clinical laboratory test results and other reasons eg, a person who does not respond to requests and instructions, or who judges the investigator to be inappropriate to participate in the clinical trial with a non-cooperative attitude
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Korea University Anam Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Chong Kun Dang Pharmaceutical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A127_01BE2206