NCT04223895

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics and Safety/Tolerability of CKD-386

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

January 8, 2020

Last Update Submit

January 8, 2020

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337

    AUCt: Area under the concentration-time curve

    0(predose)~72 hours

  • Cmax of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337

    Cmax: Maximum plasma concentration of the drug

    0(predose)~72 hours

Secondary Outcomes (6)

  • AUCinf each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337

    0(predose)~72 hours

  • tmax each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337

    0(predose)~72 hours

  • AUCt/AUCinf each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337

    0(predose)~72 hours

  • t1/2 each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337

    0(predose)~72 hours

  • AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D326, D337

    0(predose)~72 hours

  • +1 more secondary outcomes

Study Arms (6)

Group 1

EXPERIMENTAL

Period 1: D012, D326, D337(3 tabs, once) / Period 2: CKD-386 F1(1 tab, once)/ Period 3: CKD-386 F2(1 tab, once)

Drug: CKD-386 Formulation 1Drug: CKD-386 Formulation 2Drug: D012, D326 and D337

Group 2

EXPERIMENTAL

Period 1: D012, D326, D337(3 tabs, once) / Period 2: CKD-386 F2(1 tab, once)/ Period 3: CKD-386 F1(1 tab, once)

Drug: CKD-386 Formulation 1Drug: CKD-386 Formulation 2Drug: D012, D326 and D337

Group 3

EXPERIMENTAL

Period 1: CKD-386 F1(1 tab, once) / Period 2: D012, D326, D337(3 tabs, once) Period 3: CKD-386 F2(1 tab, once)

Drug: CKD-386 Formulation 1Drug: CKD-386 Formulation 2Drug: D012, D326 and D337

Group 4

EXPERIMENTAL

Period 1: CKD-386 F1(1 tab, once) / Period 2: CKD-386 F2(1 tab, once) / Period 3: D012, D326, D337(3 tabs, once)

Drug: CKD-386 Formulation 1Drug: CKD-386 Formulation 2Drug: D012, D326 and D337

Group 5

EXPERIMENTAL

Period 1: CKD-386 F2(1 tab, once) / Period 2: D012, D326, D337(3 tabs, once)/ Period 3: CKD-386 F1(1 tab, once)

Drug: CKD-386 Formulation 1Drug: CKD-386 Formulation 2Drug: D012, D326 and D337

Group 6

EXPERIMENTAL

Period 1: CKD-386 F2(1 tab, once) / Period 2: CKD-386 F1(1 tab, once) / Period 3: D012, D326, D337(3 tabs, once)

Drug: CKD-386 Formulation 1Drug: CKD-386 Formulation 2Drug: D012, D326 and D337

Interventions

CKD-386 Formulation 1DRUG

A single oral dose of 1 tablet under fasting conditions for each period

Also known as: CKD-386 F1
Group 1Group 2Group 3Group 4Group 5Group 6
CKD-386 Formulation 2DRUG

A single oral dose of 1 tablet under fasting conditions for each period

Also known as: CKD-386 F2
Group 1Group 2Group 3Group 4Group 5Group 6
D012, D326 and D337DRUG

A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period

Group 1Group 2Group 3Group 4Group 5Group 6

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those who are over 19 years old at the screening visit
  • Those who weigh more than 50kg (45kg or more for women) at the screening visit and have a body mass index (BMI) within the range of 18-30kg/m\^2
  • Those who meet the following conditions of blood pressure measured in a sitting position after sufficient rest at the screening visit
  • Systolic blood pressure: 90mmHg or more and 139mmHg or less
  • Diastolic blood pressure: 60mmHg or more and 89mmHg or less
  • Those who no congenital or chronic disease based on screening and no pathological symptoms or findings in medical examination results (e.g. EEG, ECG, chest and gastroscopy or gastrointestinal radiographs, if necessary)
  • The person in charge of the examination (or authorized test physician) who has determined that the test subject is suitable for the diagnostic test and electrocardiogram test such as hematology test, blood chemistry test, serology test and urine test performed according to the characteristics of the investigational drug product
  • Persons agreeing to exclude the possibility of pregnancy using appropriate contraceptive methods and not providing sperm or eggs from the date of first administration of the investigational drug to the 14th day after the last administration of the investigational drug

You may not qualify if:

  • Those who participated in other clinical trials (including bioequivalence studies) within 6 months before the first dose and received the investigational drug
  • Those who used drugs that induce and inhibit metabolic enzymes, such as barbital drugs, within one month before the first dose, or who used drugs that may interfere with this test within 10 days before the first dose
  • Those who have donated whole blood within 2 months before the first dose or component donation within 1 month, or have transfused within 1 month
  • Those who have had a history of gastrointestinal resection that may affect the absorption of the investigational drug (except appendectomy and hernia surgery)
  • A person who meets the following conditions within one month before the first administration date
  • Excess alcohol: 21 cups / week for men and 14 cups / week for women.
  • \[1 glass = 50 mL of shochu or 30 mL of liquor or 250 mL of beer\]
  • Smokers exceeding 20 cigarettes per day
  • Patients with the following diseases
  • Patients with hypersensitivity to the main constituents or components of the investigational drug
  • Severe hepatic impairment, biliary atresia or cholestasis
  • Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists
  • Diabetes mellitus
  • Patients with moderate to severe renal impairment \[glomerular filtration rate (eGFR) \<60 mL / min / 1.73m\^2\]
  • Renal vascular hypertension patients
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • 70-4665-9174 70-4665-9174

    H Plus Yangji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yook-Hwan Noh

CONTACT

82-70-4665-9174yook.noh@gmail.com

Jae Ri Bae

CONTACT

82-2-2194-0468jaeri@ckdpharm.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 10, 2020

Study Start

February 1, 2020

Primary Completion

March 4, 2020

Study Completion

June 15, 2020

Last Updated

January 10, 2020

Record last verified: 2020-01