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

NCT ID: NCT04678388

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-29

Study Completion Date

2020-12-12

Brief Summary

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

Detailed Description

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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

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

Reference drug

Intervention Type DRUG

1 Cap., single oral administration under fasting condition

Test drug 1

Intervention Type DRUG

1 Tab., single oral administration under fasting condition

Test drug 2

Intervention Type DRUG

1 Tab., single oral administration under fasting condition

Group 2

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

Group Type EXPERIMENTAL

Reference drug

Intervention Type DRUG

1 Cap., single oral administration under fasting condition

Test drug 1

Intervention Type DRUG

1 Tab., single oral administration under fasting condition

Test drug 2

Intervention Type DRUG

1 Tab., single oral administration under fasting condition

Group 3

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

Group Type EXPERIMENTAL

Reference drug

Intervention Type DRUG

1 Cap., single oral administration under fasting condition

Test drug 1

Intervention Type DRUG

1 Tab., single oral administration under fasting condition

Test drug 2

Intervention Type DRUG

1 Tab., single oral administration under fasting condition

Group 4

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

Group Type EXPERIMENTAL

Reference drug

Intervention Type DRUG

1 Cap., single oral administration under fasting condition

Test drug 1

Intervention Type DRUG

1 Tab., single oral administration under fasting condition

Test drug 2

Intervention Type DRUG

1 Tab., single oral administration under fasting condition

Group 5

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

Group Type EXPERIMENTAL

Reference drug

Intervention Type DRUG

1 Cap., single oral administration under fasting condition

Test drug 1

Intervention Type DRUG

1 Tab., single oral administration under fasting condition

Test drug 2

Intervention Type DRUG

1 Tab., single oral administration under fasting condition

Group 6

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

Group Type EXPERIMENTAL

Reference drug

Intervention Type DRUG

1 Cap., single oral administration under fasting condition

Test drug 1

Intervention Type DRUG

1 Tab., single oral administration under fasting condition

Test drug 2

Intervention Type DRUG

1 Tab., single oral administration under fasting condition

Interventions

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Reference drug

1 Cap., single oral administration under fasting condition

Intervention Type DRUG

Test drug 1

1 Tab., single oral administration under fasting condition

Intervention Type DRUG

Test drug 2

1 Tab., single oral administration under fasting condition

Intervention Type DRUG

Other Intervention Names

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D744 CKD-385 64 mg formulation I (878mg) CKD-385 64 mg formulation I (878mg)

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min-gi Kim

Role: PRINCIPAL_INVESTIGATOR

CENTRAL HOSPITAL

Locations

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Central Hospital

Gyeonggi-do, Siheung-si, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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A88_08BE2015P

Identifier Type: -

Identifier Source: org_study_id