A Clinical Trial to Evaluate the Pharmacokinetics and Safety of SIPS-2209-1 in Healthy Korean Volunteers

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate of bioequivalence between fixed-dose combination and co-administration of the individual components under fasting conditions in healthy Korean volunteers.

Detailed Description
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40 healthy subjects are administered the corresponding drug for each period, and the drug wash-out period is set to 7 days. Pharmacokinetic samples are collected for up to 36 hours. Pharmacokinetic parameters are compared to evaluate bioequivalence, and additionally, safety are evaluated.

Official Title
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A Clinical Trial to Compare and Evaluate the Safety and Bioequivalence of After Concomitant Administration of SIPS-2209-2 and SIPS-2209-3 and Single Administration of SIPS-2209-1 in Healthy Adult Volunteers in Fasting Conditions.

Conditions
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Healthy

Intervention / Treatment
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* Drug: SIPS-2209-1
* Drug: SIPS-2209-2, SIPS-2209-3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult volunteers aged ≥ 19 years Male for body weight ≥50 kg, female for body weight ≥45 kg Calculated body mass index (BMI) of 18 to 30 kg/m2 Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and ECG results at screening. Those who agree to contraception during the participation of clinical trial. Those who agrees to exclude the possibility of pregnancy by using a medically accepted method of contraception from the first administration of investigational medicine to 7 days after the last administration of investigational medicine Exclusion Criteria: Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products. Those who donated whole blood or apheresis within 8 weeks or 2 weeks respectfully, or received blood transfusion within a month. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery. Those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products. Alcohol: Man - 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) Patients with the following diseases Patients with known hypersensitivity reactions such as anaphylaxis or angioedema to investigational drugs and components Patients with pancreatitis Patients with heart failure or a history of heart failure Patients with active bladder cancer or a history of bladder cancer Patients with hepatic impairment Patients with severe renal impairment Patients with diabetic ketoacidosis, diabetic coma and pre-coma, patients with type 1 diabetes Before and after surgery, patients with severe infections, patients with severe trauma Patients with gross hematuria not investigated Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Those who are deemed insufficient to participate in this clinical trial by investigators. Woman who are pregnant or breastfeeding. Those who have a history of clinically significant mental illness

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

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: Sequence A<br>Period 1: SIPS-2209-1 - A single oral dose of 1 tablet under fasting condition Period 2: SIPS-2209-2, SIPS-2209-3 - A single oral dose of 2 tablets under fasting condition | Drug: SIPS-2209-1<br>* QD, PO<br>Drug: SIPS-2209-2, SIPS-2209-3<br>* QD, PO<br>|
| Experimental: Sequence B<br>Period 1: SIPS-2209-2, SIPS-2209-3 - A single oral dose of 2 tablets under fasting condition Period 2: SIPS-2209-1 - A single oral dose of 1 tablet under fasting condition | Drug: SIPS-2209-1<br>* QD, PO<br>Drug: SIPS-2209-2, SIPS-2209-3<br>* QD, PO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of SIPS-2209-1 | AUCt: Area under the concentration-time curve from time zero to time | predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours | 
| Cmax of SIPS-2209-1 | Cmax: Maximum plasma concentration of the drug | predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of SIPS-2209-1 | AUCinf : AUC from time 0 to infinity | predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours | 
| CL/F of SIPS-2209-1 | CL/F : Clearance | predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours | 
| Tmax of SIPS-2209-1 | Tmax : Time to maximum plasma concentration of drug | predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours | 
| t1/2 of SIPS-2209-1 | t1/2 : Terminal half-life | predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours | 
| Vd/F of SIPS-2209-1 | Vd/F : Volume of distribution based on the terminal phase | predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, Fixed-dose combination, Bioequivalence