NCT05945810

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

Evaluation of TLL-018 Extended Release Formulation (ER, 50 mg QD) and TLL-018 Immediate-release Formulation (IR, 20 mg BID) for Human Bioequivalence Testing in Single Dose and Steady State in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. The main questions it aims to answer are: * Sectionalization - subjects are divided into two sequences (A/B) equally of 14 subjects each * Phases - The study is divided into 4 phases, screening, cycle 1, cycle 2 and follow-up observation period. The screening period is from D-7 to D-1, with subjects admitted to the phase I clinical trial ward at D-1. D1 starts the first cycle of the trail until D7 ends; After a 3-day washout period, D11 begins the second cycle of administration until D17 ended. D18\~D20 are the follow-up observation period. The total study duration is 27 days. * Medication - All subjects were administered after meal. Participants in sequence A will receive oral administration of 50 mg TLL-018 extended-release tablet once on day 1 for the first cycle, and then continue to receive the same dosage once daily for 5 consecutive days from day 3. After a 3-day washout period, they will enter the second cycle and will receive one oral dose of 20 mg TLL-018 immediate-release tablet in the morning of day 11, followed by a second dose of 20 at night 12 hours later, then continued to receive 20 mg TLL-018 twice daily for 5 consecutive days from day 13. Hospital observation for 3 days after taking the medication.. Participants in sequence B will receive 20 mg TLL-018 immediate-release tablet in the first cycle and 50 mg TLL-018 extended-release tablet in the second cycle, with the same medication pattern as those in sequence A.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	TLL-018 extended-release tablet	50mg TLL-018 extended-release tablet QD
DRUG	TLL-018 immediate-release tablet	20mg TLL-018 immediate-release tablet BID

Timeline

• Start date: 2023-07-12
• Primary completion: 2023-08-28
• Completion: 2023-08-28
• First posted: 2023-07-14
• Last updated: 2024-03-01

Locations

1 site across 1 country: China