NCT06132243CompletedPhase 1
Comparative Study on Pharmacokinetics of Two Formulations of Jaktinib in Healthy Adults Under Fasting Conditions
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
Source: ClinicalTrials.gov · Last updated 11 Jan 2024
Brief summary (registry, in English)
To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 9 Nov 2023
- Start date
- Nov 2023
- Primary completion date
- Dec 2023
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT06132243
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 52
- From Nov 2023 to the primary completion date, Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who were enrolled in a clinical trial or used a study drug within 3 months before administration of the study drug;
Other illness
- 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);
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Hospital of Changsha Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.