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Clinical Trial to Compare the PK of the Fixed-dose Combinations and Each Component of Gemigliptin/Dapagliflozin 50/10 mg

NCT ID: NCT04544319

Last Updated: 2020-09-11

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

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2021-07-31

Brief Summary

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To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg

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Detailed Description

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To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg Also we identify safety and tolerance of FDC and each component

Conditions

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T2DM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Arm I

Firstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg

Group Type EXPERIMENTAL

Zemiglo 50mg and Forxiga 10mg

Intervention Type DRUG

Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD

Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg

Intervention Type DRUG

Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD

Arm II

Firstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg

Group Type EXPERIMENTAL

Zemiglo 50mg and Forxiga 10mg

Intervention Type DRUG

Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD

Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg

Intervention Type DRUG

Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD

Interventions

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Zemiglo 50mg and Forxiga 10mg

Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD

Intervention Type DRUG

Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg

Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD

Intervention Type DRUG

Other Intervention Names

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zemiglo and Forxiga zemiglo and Forxiga

Eligibility Criteria

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Inclusion Criteria

1. Healthy adults who are 19 years \~ 50 years when they are screened
2. weight: 55.0 kg \~ 90.0 kg and BMI: 18.0 kg/m2 \~ 30.0 kg/m2
3. Volunteers who understand the procedures of clinical trial and signed informed consent form
4. Volunteers who are eligible decided by vital signs, physical examination, lab test and 12-lead ECG
5. Women of chlidbearing potential have negative results in pregnancy test

Exclusion Criteria

1. Healtjy volunteers who don't have clinically significant disease such as liver disease, severe renal disease, acute pancreatitis... etc
2. Drug Allergy in aspirin, NSAID, Anti-bacterial drugs
3. GI tract diseases which affect PK results and safety such as ulceritis, GERD, chron disease...
4. Chronic urine track infection
5. Allergy history in sunset yellow 5 pigment and Fast green FCF (pigment)
6. galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
7. These resluts are appeared when screening

* ALT, AST \>= 1.5 Upper limit of normal range
* HbsAg, anti-HCV, HIV Ag\&Ab positive
* MDRD equation: eGFR\< 60 mL/min/1.73m2
* QTcB\> 450 ms
* Fasting serum glucose \< 70mg/dL or \>110mg/dL
* HbA1c\>6.5%
8. SBP\<90mmHg or \>150mmHg, DBP \<60mmHg or \>100mmHg
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LG Chem

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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seunghwan Lee

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Central Contacts

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songyi park

Role: CONTACT

[email protected]
02-6987-4195

clinical LG Chem

Role: CONTACT

[email protected]

Other Identifiers

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LG-GLCL002

Identifier Type: -

Identifier Source: org_study_id

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