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Completed

NCT Number: NCT04914221

The Safety and PK Characteristics of the Co-administration of JLP-2002 and Comparator in Healthy Volunteers

A randomized, open-label, single-dose, replicate crossover study to compare the pharmacokinetics and safety in healthy adult volunteers following oral administration of JLP-2002

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Key information

Conditions

Overactive Bladder(OAB) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

A randomized, open-label, single-dose, replicate crossover study

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Those who are 19 years of age or older and 55 years of age
  • BMI 18.5 ~ 27.5 kg/m2
  • Those who voluntarily agrees in writing after hearing a sufficient explanation of the purpose and procedure of the clinical trial

Exclusion criteria

  • Those with clinically significant diseases or a history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, respiratory system, neuropsychiatric system, blood/oncology system, etc.
  • Those with a history of gastrointestinal diseases or surgery that may affect the absorption of drugs
  • Those who donated whole blood within 60 days from the date of eligibility assessment, or who donated component blood within 30 days
  • Those who do not have a medically recognized contraceptive intention or plan to provide sperm from the screening date to 4 weeks from the last administration of the investigational drug
  • Those whose blood AST, ALT, or GGT levels in the screening test exceeded 3 times the upper limit of the reference range
  • Those who showed clinically significant results in the hepatitis B test, hepatitis C test, HIV test, and syphilis test
  • In the case of women, those who do not show a negative response on the pregnancy test
  • Those who judged that the investigator is not suitable for participation in clinical trials, such as showing clinically significant results in other screening tests

Treatment and study plan

JLP-2002

Drug

administration of JLP-2002

Comparator

Drug

administration of comparator

Primary outcomes

  1. AUClast of JLP-2002

    Time frame: Time Frame: 192 hours

  2. Cmax of JLP-2002

    Time frame: Time Frame: 192 hours

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Single-dose, Replicate Crossover Study to Compare the Pharmacokinetics and Safety in Healthy Adult Volunteers Following Oral Administration of JLP-2002

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2021
Registry last updated
Jun 14, 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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