Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-393 in Healthy Subjects
Study Details
Study Description
Brief Summary
This study is an open-label, randomized, fed, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-393 in healthy subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: 1) CKD-501 0.5mg 2) D759 3) D150 Test drug: 1) CKD-393 0.5/100/1000mg formulation Ⅰ Tab. 2) CKD-393 0.5/100/1000mg formulation Ⅱ Tab.
Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 Period 1: Treatment A Period 2: Treatment B Period 3: Treatment C |
Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T
single oral administration under fed condition
Other Names:
Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T
single oral administration under fed condition
Other Names:
Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
single oral administration under fed condition
Other Names:
|
| Experimental: Group 2 Period 1: Treatment A Period 2: Treatment C Period 3: Treatment B |
Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T
single oral administration under fed condition
Other Names:
Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T
single oral administration under fed condition
Other Names:
Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
single oral administration under fed condition
Other Names:
|
| Experimental: Group 3 Period 1: Treatment B Period 2: Treatment A Period 3: Treatment C |
Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T
single oral administration under fed condition
Other Names:
Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T
single oral administration under fed condition
Other Names:
Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
single oral administration under fed condition
Other Names:
|
| Experimental: Group 4 Period 1: Treatment B Period 2: Treatment C Period 3: Treatment A |
Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T
single oral administration under fed condition
Other Names:
Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T
single oral administration under fed condition
Other Names:
Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
single oral administration under fed condition
Other Names:
|
| Experimental: Group 5 Period 1: Treatment C Period 2: Treatment A Period 3: Treatment B |
Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T
single oral administration under fed condition
Other Names:
Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T
single oral administration under fed condition
Other Names:
Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
single oral administration under fed condition
Other Names:
|
| Experimental: Group 6 Period 1: Treatment C Period 2: Treatment B Period 3: Treatment A |
Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T
single oral administration under fed condition
Other Names:
Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T
single oral administration under fed condition
Other Names:
Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
single oral administration under fed condition
Other Names:
|
Outcome Measures
Primary Outcome Measures
- AUCt of CKD-501, D759, D150, CKD-393 [Time Frame: 0 hour ~ 48 hours]
Area under the CKD-501/D759/D150/CKD-393 concentration in blood-time curve from zero to final
- Cmax of CKD-501, D759, D150, CKD-393 [Time Frame: 0 hour ~ 48 hours]
The maximum CKD-501/D759/D150/CKD-393 concentration in blood sampling time t
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy male volunteers, aged between ≥ 19 and ≤ 55 years old at the time of screening.
-
Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2
- BMI = Weight(kg)/ Height(m)2
-
Subject who consents to use at least two clinically effective birth controls for at least 1 month following the last dose.
-
Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written.
Exclusion Criteria:
-
History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic or psychiatric disorder.
-
With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.
-
Any medical history that may affect drug absorption, distribution, metabolism and excretion.
-
Individuals who had history of hypersensitivity to follow drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) or had history of drug abuse
-
Thiazolidinedione
-
DPP-4 inhibitor
-
Metformin
-
Any clinically significant chronic medical illness.
-
Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
-
Individuals with one of the following laboratory test results in screening
-
AST, ALT > UNL (upper normal limit) x 3
-
fasting glucose < 70 mg/dL or > 125 mg/dL
-
Creatinine clearance ≤ 80 mL/min
-
In ECG result, QTc > 450 msec
-
hCG(+) (only women)
-
Individuals who had positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
-
Use of any prescription drugs within 14 days prior to study drug administration.
-
Use of over-the-counter medications and herbal preparations within 7 days prior to study drug administration.
-
History of any clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not required medication may be allowed).
-
Individuals who cannot eat standard meal provided from clinical trial center.
-
Donation of blood within 60 days prior to study drug administration or apheresis within 20 days prior to the first IP administration.
-
Individuals who had received a blood transfusion within 30 days prior to study drug administration.
-
Exposure to any investigational drug within 6 months prior to the first IP administration.
-
Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
-
Individuals who had consumed grapefruit juice > 5cups/day or caffeine > 5cups/day within 30 days prior to the first IP administration or who cannot stopping consume grapefruit juice or caffeine during clinical study.
-
Individuals who had drinking (alcohol > 30 g/day) within 30 days prior to the first IP administration or who cannot stopping drink.
-
Heavy smoking (more than 10 cigarettes/day) within 30 days prior to screening or who cannot quit smoking during clinical study.
-
Pregnant or women who may be pregnant
-
Subjects having been deemed inappropriate for the trial as determined by the investigator.
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.- A98_01BE1922P