Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fasting Conditions

Chong Kun Dang

Status and phase: Unknown; Phase 1

Conditions: Cardiovascular Diseases

Treatments: Drug: Test drug 1; Drug: Test drug 2; Drug: Reference drug

Study type: Interventional

Funder types: Industry

Identifiers

NCT04678388

A88_08BE2015P

Details and patient eligibility

About

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under Fasting Conditions

Full description

A randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fasting conditions

Enrollment: 24 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adult aged more than 19 at the time of screening

2. Those who had 18.0kg/m² ≤ Body Mass Index (BMI) < 30.0kg/m²

   BMI=Weight(kg) / Height(m)²

3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination.

4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening.

5. Those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations.

6. Those who agree to double contraception method from the 1st administration of the investigational product until 7 days after the last administration of investigational product.

Exclusion criteria

1. Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, impacted teeth, wisdom teeth).
2. Those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug.
3. Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening.
4. Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs.
5. Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products.
6. Those who have taken any drugs that may affect the clinical trial within 10 days.
7. Those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products.
8. Those who are deemed insufficient to participate in this clinical study by investigators.

Details and patient eligibility

About

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under Fasting Conditions

Full description

A randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fasting conditions

Enrollment: 24 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adult aged more than 19 at the time of screening

2. Those who had 18.0kg/m² ≤ Body Mass Index (BMI) < 30.0kg/m²

   BMI=Weight(kg) / Height(m)²

3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination.

4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening.

5. Those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations.

6. Those who agree to double contraception method from the 1st administration of the investigational product until 7 days after the last administration of investigational product.

Exclusion criteria

1. Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, impacted teeth, wisdom teeth).
2. Those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug.
3. Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening.
4. Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs.
5. Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products.
6. Those who have taken any drugs that may affect the clinical trial within 10 days.
7. Those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products.
8. Those who are deemed insufficient to participate in this clinical study by investigators.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Group 1

Experimental group

Description:

1. Period 1: Reference drug 2. Period 2: Test drug 1 3. Period 3: Test drug 2

Treatment:

Drug: Test drug 2

Drug: Reference drug

Drug: Test drug 1

Group 2

Experimental group

Description:

1. Period 1: Test drug 2 2. Period 2: Reference drug 3. Period 3: Test drug 1

Treatment:

Drug: Test drug 2

Drug: Reference drug

Drug: Test drug 1

Group 3

Experimental group

Description:

1. Period 1: Test drug 1 2. Period 2: Test drug 2 3. Period 3: Reference drug

Treatment:

Drug: Test drug 2

Drug: Reference drug

Drug: Test drug 1

Group 4

Experimental group

Description:

1. Period 1: Test drug 2 2. Period 2: Test drug 1 3. Period 3: Reference drug

Treatment:

Drug: Test drug 2

Drug: Reference drug

Drug: Test drug 1

Group 5

Experimental group

Description:

1. Period 1: Test drug 1 2. Period 2: Reference drug 3. Period 3: Test drug 2

Treatment:

Drug: Test drug 2

Drug: Reference drug

Drug: Test drug 1

Group 6

Experimental group

Description:

1. Period 1: Reference drug 2. Period 2: Test drug 2 3. Period 3: Test drug 1

Treatment:

Drug: Test drug 2

Drug: Reference drug

Drug: Test drug 1