NCT05066516

Brief Summary

This study was conducted as a randomized, open-label, single-dose, crossover study design. All participants were randomly allocated for group A (Period 1: Individual components (ICs), period 2: FCDP) and group B (Period 1: FCDP, period 2: ICs), and each group was administered either a single dose of IN-C009 (FCDP, dapagliflozin 10mg/linagliptin 5 mg) (HK inno.N., Seoul, Korea) or co-administration of a single dose of dapagliflozin (Forxiga 10 mg, AstraZeneca, Cambridge, England, UK) and linagliptin (Trajenta 5mg, Beringer-Ingelheim, Ingelheim, Germany) after at least 10 hours of overnight fasting. After the 28 days of the washout period, the participants received the opposite treatment (Group A: IN-C009; Group B: dapagliflozin and linagliptin). The dosage of dapagliflozin and linagliptin in the study is commercially used and recommended amount for the control of T2DM currently. On the day 1 (the day of each drug administration), the serial blood samples were drawn immediately before (0 h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for dapagliflozin), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for linagliptin) after the each dosing to assess pharmacokinetics of each drugs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 25, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

September 14, 2021

Last Update Submit

September 24, 2021

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Cmax

    peak plasma concentration

    72 hours

  • AUC

    area under plasma concentration versus time curve

    72 hours

Secondary Outcomes (4)

  • Tmax

    72 hours

  • half-life

    72 hours

  • CL

    72 hours

  • Vd

    72 hours

Study Arms (2)

Period 1: Individual components (ICs), period 2: FCDP

EXPERIMENTAL

Period 1: Individual components (ICs), period 2: FCDP

Drug: FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin

Period 1: FCDP, period 2: ICs

EXPERIMENTAL

Period 1: FCDP, period 2: ICs

Drug: FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin

Interventions

FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptinDRUG

FCDP, dapagliflozin 10mg/linagliptin 5 mg or ICs, co-administration of a single dose of dapagliflozin and linagliptin

Period 1: FCDP, period 2: ICsPeriod 1: Individual components (ICs), period 2: FCDP

Eligibility Criteria

Age19 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 19 to 45 years;
  • body weight more than 50 kg

You may not qualify if:

  • a history or evidence of hepatic, renal, gastrointestinal, or hematological abnormality;
  • hepatitis B, hepatitis C, syphilis, or HIV infection;
  • a history of hypersensitivity to dapagliflozin and/or linagliptin;
  • clinically significant allergic disease; alcohol or drug abuse;
  • heavy smoker (more than ten cigarettes per day);
  • use of any medication within 30 days before the start of the study that may affect the study results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

N(beta)-fumarylcarboxyamido-2,3-diaminopropionic aciddapagliflozinLinagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2021

First Posted

October 4, 2021

Study Start

June 25, 2020

Primary Completion

August 18, 2020

Study Completion

October 18, 2020

Last Updated

October 4, 2021

Record last verified: 2021-09

Locations

KR(1)