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Completed

NCT Number: NCT06132243

Comparative Study on Pharmacokinetics of Two Formulations of Jaktinib in Healthy Adults Under Fasting Conditions

To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers

Completed

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Third Hospital of Changsha

Changsha, Hunan, 410011, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18≤ age ≤ 45, male or female;
  • Body weight: ≥50 kg for male, ≥45 kg for female; body mass index (BMI): 19.0-26.0 kg/m^2 (inclusive);
  • Informed consent will be signed before the trial, and the content, process and possible adverse reactions of the trial will be fully understood;
  • The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.

Exclusion criteria

  • Participants who were enrolled in a clinical trial or used a study drug within 3 months before administration of the study drug;
  • Participants with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years and still clinically relevant according to the investigator;
  • Participants with definite diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic system and other diseases that require medical intervention or are not suitable for clinical trial (such as psychiatric history);
  • With positive alcohol breath test;
  • Volunteers may not be able to complete the study for other reasons or have other reasons for not participating in the study as judged by the investigator.

Treatment and study plan

Jaktinib Hydrochloride Tablets

Drug

Orally, one tablet at a time

Other names: Jaktinib

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) Of Jaktinib and its main metabolite ZG0244

    Time frame: up to 48 hours

    Maximum Plasma Concentration (Cmax)

  2. Jaktinib and its main metabolite ZG0244 AUC(0-t)

    Time frame: up to 48 hours

    Area under the concentration time curve from time 0 to time of the last quantifiable

  3. Jaktinib and its main metabolite ZG0244 AUC(0-inf)

    Time frame: up to 48 hours

    Area under the concentration time curve from time 0 to infinity

Secondary outcomes

  1. Jaktinib and its main metabolite ZG0244 Tmax

    Time frame: up to 48 hours

    Maximum Plasma Concentration (Tmax)

  2. Jaktinib and its main metabolite ZG0244 t1/2

    Time frame: up to 48 hours

    Half Life (t1/2)

  3. Adverse events

    Time frame: Day 1 to Day 12

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

A Single-dose, Randomized, Open-label, Repeated Cross-over Pharmacokinetic Comparison Study of Two Formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers Under Fasted Conditions

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2023
Registry last updated
Jan 11, 2024

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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