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

Diabetes Mellitus Clinical Trial

Official title:

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of IN-C009 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05066516
• Other study ID #: IN_DLC_101
• Status: Completed
• Phase: Phase 1
• Start date: June 25, 2020
• Est. completion date: October 18, 2020

Study information

• Verified date: September 2021
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 18, 2020
• Est. primary completion date: August 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	peak plasma concentration	72 hours
Primary	AUC	area under plasma concentration versus time curve	72 hours
Secondary	Tmax	time at Cmax	72 hours
Secondary	half-life	elimination half-life	72 hours
Secondary	CL	clearance	72 hours
Secondary	Vd	volume distribution	72 hours