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

Korea University

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05066516

IN_DLC_101

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.