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

Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin

• Registration Number: NCT05066516
• Lead Sponsor: Korea University Anam Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-25
• Primary Completion: 2020-08-18
• Study Completion: 2020-10-18
• Status Verified: 2021-09
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-24
• Last Update Submitted: 2021-09-24
• Study First Posted: 2021-10-04
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 1: FCDP, period 2: ICs	FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin	Period 1: FCDP, period 2: ICs
Period 1: Individual components (ICs), period 2: FCDP	FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin	Period 1: Individual components (ICs), period 2: FCDP

Primary Outcome Measures

Name	Time	Method
AUC	72 hours	area under plasma concentration versus time curve
Cmax	72 hours	peak plasma concentration

Secondary Outcome Measures

Name	Time	Method
Vd	72 hours	volume distribution
Tmax	72 hours	time at Cmax
CL	72 hours	clearance
half-life	72 hours	elimination half-life

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of