The Pharmacokinetics, Safety and Tolerability of IN-C009 in Healthy Subjects

Sponsor
Korea University Anam Hospital
Study ID
NCT05066516
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
MALE
Age
19 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 25, 2020
Status verified
Sep 2021
Primary completion
Aug 18, 2020
Completion
Oct 18, 2020

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Cmax [ Time Frame: 72 hours ]

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