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

• Sponsor: Korea University Anam Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05066516
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.8
• Patients Per Site Per Month: 12.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of IN-C009 in Healthy Subjects
• Actual Study Start Date: Jun 25, 2020
• Actual Primary Completion Date: Aug 18, 2020
• Actual Study Completion Date: Oct 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Period 1: Individual components (ICs), period 2: FCDP Period 1: Individual components (ICs), period 2: FCDP	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
Experimental: Period 1: FCDP, period 2: ICs Period 1: FCDP, period 2: ICs	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

Outcome Measures

Primary Outcome Measures

1. Cmax [72 hours]

   peak plasma concentration

2. AUC [72 hours]

   area under plasma concentration versus time curve

Secondary Outcome Measures

1. Tmax [72 hours]

   time at Cmax

2. half-life [72 hours]

   elimination half-life

3. CL [72 hours]

   clearance

4. Vd [72 hours]

   volume distribution

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Anam Hospital	Seoul		Korea, Republic of	02841

Sponsors and Collaborators

• Korea University Anam Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ji-Young Park, Professor, Korea University Anam Hospital
• ClinicalTrials.gov Identifier: NCT05066516
• Other Study ID Numbers: IN_DLC_101
• First Posted: Oct 4, 2021
• Last Update Posted: Oct 4, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dapagliflozin; Linagliptin

Study Results

No Results Posted as of Oct 4, 2021