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Completed

NCT Number: NCT05066516

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Anam Hospital

Seoul, 02841, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Cmax

    Time frame: 72 hours

    peak plasma concentration

  2. AUC

    Time frame: 72 hours

    area under plasma concentration versus time curve

Secondary outcomes

  1. Tmax

    Time frame: 72 hours

    time at Cmax

  2. half-life

    Time frame: 72 hours

    elimination half-life

  3. CL

    Time frame: 72 hours

    clearance

  4. Vd

    Time frame: 72 hours

    volume distribution

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 4, 2021
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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