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

Samik Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SIPS-2209-2, SIPS-2209-3; Drug: SIPS-2209-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05787873

SIPS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adult volunteers aged ≥ 19 years
2. Male for body weight ≥50 kg, female for body weight ≥45 kg
3. Calculated body mass index (BMI) of 18 to 30 kg/m2
4. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and ECG results at screening.
6. Those who agree to contraception during the participation of clinical trial.
7. 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

1. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.

2. 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.

3. Those who donated whole blood or apheresis within 8 weeks or 2 weeks respectfully, or received blood transfusion within a month.

4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.

5. 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)

6. 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.

7. Those who are deemed insufficient to participate in this clinical trial by investigators.

8. Woman who are pregnant or breastfeeding.

9. Those who have a history of clinically significant mental illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Sequence A

Experimental group

Description:

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

Treatment:

Drug: SIPS-2209-2, SIPS-2209-3

Drug: SIPS-2209-1

Sequence B

Experimental group

Description:

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

Treatment:

Drug: SIPS-2209-2, SIPS-2209-3

Drug: SIPS-2209-1