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

NCT ID: NCT05066516

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-25
• Study Completion Date: 2020-10-18

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Period 1: FCDP, period 2: ICs

Period 1: FCDP, period 2: ICs

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

FCDP, dapagliflozin 10mg/linagliptin 5 mg or ICs, 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 linagliptin

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ji-Young Park

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Korea University Anam Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

IN_DLC_101

Identifier Type: -

Identifier Source: org_study_id