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Completed

NCT Number: NCT04764201

The Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2001 and HGP2001 in healthy volunteers.

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Key information

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jeonbuk University Hospital

Jeonju, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 19 kg/m^2 ≤ BMI < 28 kg/m^2, weight >60kg
  • 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <900 mmHg
  • agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.

Exclusion criteria

  • A history of hypersensitivity reactions or clinically significant hypersensitivity reactions
  • A history of gastrointestinal diseases or surgery that may affect the absorption of clinical trial drugs
  • A history of substance abuse or who test positive for drugs of concern for abuse in the urine drug screening test
  • Positive results of serological tests
  • Have taken other investigational drugs or bioequivalence drugs within 6 months before the first administration of the investigational drug
  • Donated whole blood within 60 days prior to the screening date or donated components within 30 days or received a blood transfusion within 30 days
  • Have drank more than 210 g/week of alcohol within 30 days before the screening date
  • Have smoked more than 10 bills/day within 30 days before the screening date
  • AST, ALT value is more than 2 times the UNL or bilirubin level is more than 1.5 times the UNL, eGFR < 50 mL/min/1.73m2, Prothrombin (INR) > 1.31 INR or aPTT > 39.7 sec
  • 12-ECG QTc >450 ms

Treatment and study plan

HIP2001

Drug

Test drug

HGP2001

Drug

Reference drug

Primary outcomes

  1. AUCt

    Time frame: 0~48 hours

    Pharmacokinetic evaluation

  2. Cmax

    Time frame: 0~48 hours

    Pharmacokinetic evaluation

Secondary outcomes

  1. AUCinf

    Time frame: 0~48 hours

    Pharmacokinetic evaluation

  2. Tmax

    Time frame: 0~48 hours

    Pharmacokinetic evaluation

  3. t1/2

    Time frame: 0~48 hours

    Pharmacokinetic evaluation

  4. CL/F

    Time frame: 0~48 hours

    Pharmacokinetic evaluation

  5. Vd/F

    Time frame: 0~48 hours

    Pharmacokinetic evaluation

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Apr 1, 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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