The Pharmacokinetics, Safety and Tolerability of IN-C009 in Healthy Subjects

Study Overview
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Brief Summary
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This study was conducted as a randomized, open-label, single-dose, crossover study design. All participants were randomly allocated for group A (Period 1: Individual components (ICs), period 2: FCDP) and group B (Period 1: FCDP, period 2: ICs), and each group was administered either a single dose of IN-C009 (FCDP, dapagliflozin 10mg/linagliptin 5 mg) (HK inno.N., Seoul, Korea) or co-administration of a single dose of dapagliflozin (Forxiga 10 mg, AstraZeneca, Cambridge, England, UK) and linagliptin (Trajenta 5mg, Beringer-Ingelheim, Ingelheim, Germany) after at least 10 hours of overnight fasting. After the 28 days of the washout period, the participants received the opposite treatment (Group A: IN-C009; Group B: dapagliflozin and linagliptin). The dosage of dapagliflozin and linagliptin in the study is commercially used and recommended amount for the control of T2DM currently. On the day 1 (the day of each drug administration), the serial blood samples were drawn immediately before (0 h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for dapagliflozin), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for linagliptin) after the each dosing to assess pharmacokinetics of each drugs.

Official Title
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An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of IN-C009 in Healthy Subjects

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 19 to 45 years; body weight more than 50 kg Exclusion Criteria: a history or evidence of hepatic, renal, gastrointestinal, or hematological abnormality; hepatitis B, hepatitis C, syphilis, or HIV infection; a history of hypersensitivity to dapagliflozin and/or linagliptin; clinically significant allergic disease; alcohol or drug abuse; heavy smoker (more than ten cigarettes per day); use of any medication within 30 days before the start of the study that may affect the study results.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1: Individual components (ICs), period 2: FCDP<br>Period 1: Individual components (ICs), period 2: FCDP | Drug: FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin<br>* FCDP, dapagliflozin 10mg/linagliptin 5 mg or ICs, co-administration of a single dose of dapagliflozin and linagliptin<br>|
| Experimental: Period 1: FCDP, period 2: ICs<br>Period 1: FCDP, period 2: ICs | Drug: FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin<br>* FCDP, dapagliflozin 10mg/linagliptin 5 mg or ICs, co-administration of a single dose of dapagliflozin and linagliptin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | peak plasma concentration | 72 hours | 
| AUC | area under plasma concentration versus time curve | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | time at Cmax | 72 hours | 
| half-life | elimination half-life | 72 hours | 
| CL | clearance | 72 hours | 
| Vd | volume distribution | 72 hours |