Evaluation of TLL-018 Extended and Immediate Release Formulation for Bioequivalence Testing in Healthy Chinese Subjects

• Status: Completed
• Trial end date: 2023-08-28
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this two-sequence, two-cycle, single and multiple-dose Phase I clinical trial is To evaluate the human bioequivalence of the test preparation and the reference preparation in 28 healthy chinese subjects at a single center.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd

Criteria

Inclusion Criteria:

1. The subjects can fully understand the purpose, method and possible adverse event of the study and are willing to participate and sign informed consent form prior to any study procedure;

2. 18-45 years (including 18 and 45 years);

3. weigh: Male ≥50.0 kg, female ≥ 45.0kg, BMI between 19.0 and 26.0 kg/m2 (including boundary value);

4. Without chronic or serious diseases history in cardiovascular, liver, kidney, blood and lymphatic, endocrine, immune, spiritual, menstrual and gastrointestinal systems, without dysphagia or any other effects on drug absorption history, no family history of genetic disease, and generally in good health;

5. Vital signs examination (including boundary value) : systolic blood pressure 90~139mmHg, diastolic blood pressure 60-89 mmHg, pulse 55-100 beats/min, body temperature (ear temperature) 36.0~37.4℃. Physical examination, clinical laboratory examination, 12-lead electrocardiogram, anterolateral chest radiograph, Abdominal B-ultrasonography results all show no abnormality or no clinical significance;

6. Female subjects are non-pregnant or non-lactating, and subjects and their partners are voluntary use of contraception deemed effective by the investigator for at least 4 weeks after the last investigational drug ;

7. The subject is able to communicate well with the investigator and understand and comply with all aspects of the study.

Exclusion Criteria:

1. People with a history of allergies, including but not limited to research drugs, foods or other substances;

2. Any history of surgery, trauma that may affect the safety of the study or the in vivo course of the drug, or Patients scheduled to undergo surgery during the study period;

3. Active or latent or inadequately treated mycobacterium tuberculosis infection in the 3 months prior to screening;

4. Patients with clinically significant symptoms of infection within 30 days prior to screening or acute illness prior to the use of the investigational drug.

5. Subjects with a history of herpes zoster within 1 year prior to screening; Subjects with a history of recurrent (unlimited) herpes zoster or disseminated herpes simplex or herpes zoster (even if only once);

6. Those who received vaccination within 30 days prior to screening or planned to receive vaccination during the study period