Food Effect and Mass Balance Study of XZP-3621 Tablets
NCT05034120 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2025-05-25
Summary
This is a single-center, open-label, single-dose phase I study, the study is divided into two stages. The stage 1 is to investigate the absorption, metabolism and excretion of XZP-3621 tablets in healthy Chinese subjects. The stage 2 is to evaluate the effect of food on the Pharmacokinetics of single-dose XZP-3621 tablets in Chinese Healthy Volunteers. In addition, the safety of XZP-3621 tablets in Chinese Healthy Volunteers will also be evaluated.
Conditions
- Healthy
Interventions
- DRUG
-
XZP-3621
Administer a single dose of XZP-3621 tablet after a low-fat meal.
- DRUG
-
XZP-3621
Cycle1(D1-D9): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a standard meal in a single dose on Day19.
- DRUG
-
XZP-3621
Cycle1(D1-D9) : Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a standard meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after on an empty stomach in a single dose on Day19.
- DRUG
-
XZP-3621
Cycle1(D1-D9): Administer the XZP-3621 tablet after a standard meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day19.
- DRUG
-
XZP-3621
Cycle1(D1-D9) : Administer the XZP-3621 tablet on an empty stomach in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a standard meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day19.
- DRUG
-
XZP-3621
Cycle1(D1-D9): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a standard meal in a single dose on Day19.
- DRUG
-
XZP-3621
Cycle1(D1-D9): Administer the XZP-3621 tablet after a standard meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day19.
Sponsors & Collaborators
-
Xuanzhu Biopharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Yu Cao · The Affiliated Hospital of Qingdao University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-12-23
- Primary Completion
- 2022-03-30
- Completion
- 2022-03-30
Countries
- China
Study Locations
More Related Trials
-
Study of the Effect of Food Intake on the Bioavailability of XC221 100 mg Tablets
NCT05295121 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants
NCT05431153 ·Status: COMPLETED ·Phase: PHASE1
-
Food Effect Study of HSK47388 in Healthy Subjects
NCT07192692 ·Status: COMPLETED ·Phase: PHASE1
-
Single and Multiple Ascending Dose Safety Study of XPF-001 in Healthy Volunteers
NCT00813670 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants
NCT06270511 ·Status: COMPLETED ·Phase: PHASE1
-
Study on the Food Effects of Oral SHR4640 Tablets in Healthy Volunteers
NCT04620408 ·Status: UNKNOWN ·Phase: PHASE1
-
A Food Effect Study of SPH5030 Tablets.
NCT06372223 ·Status: COMPLETED ·Phase: PHASE1
-
A Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649
NCT02151617 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluate the Effects of Food on the Pharmacokinetics of SIM0270
NCT06536036 ·Status: COMPLETED ·Phase: PHASE1
-
The Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects
NCT03249753 ·Status: COMPLETED ·Phase: PHASE1
-
Food Effect Study of a Single Dose of ZD4054 (Zibotentan)
NCT00710047 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effect of Different Meal Types on the Pharmacokinetics of DBPR108 in Healthy Subjects
NCT05150626 ·Status: COMPLETED ·Phase: PHASE1
-
A Food-Effect Study of AND017 in Healthy Participants
NCT04712500 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Food Effect on RNK08954 in Healthy Participants, and the Mass Balance Study of [14C]RNK08954 in Healthy Adult Male Subjects
NCT07334262 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162
NCT01691274 ·Status: COMPLETED ·Phase: PHASE1
-
A Food-Effect Study of CX11 in Healthy Participants
NCT07349381 ·Status: RECRUITING ·Phase: PHASE1
-
Pharmacokinetic Study of SH-1028 Tablets in Healthy Subjects Under Fasting and Fed Conditions
NCT03973632 ·Status: UNKNOWN ·Phase: PHASE1
-
To Evaluate Effect of Food of DA-5222 in Healthy Adult Subjects
NCT06993168 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RSS0343 Tablets in Healthy Subjects After Single and Multiple Oral Administration and the Effect of Food on the Pharmacokinetics of RSS0343
NCT07101965 ·Status: COMPLETED ·Phase: PHASE1
-
A Food-Effect Study of BPI-16350 in Healthy Subjects
NCT05316259 ·Status: COMPLETED ·Phase: PHASE1
-
A Single and Multiple Dose Study to Explore the Safety Of JNJ-40346527 In Healthy Volunteers
NCT01054014 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Characterize the Pharmacokinetics and Effect of Food on JNJ-31001074 in Healthy Volunteers
NCT00915434 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess Pharmacokinetics, Safety and Tolerability of PF-04965842 in Chinese Healthy Participants
NCT04099563 ·Status: COMPLETED ·Phase: PHASE1
-
A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects
NCT04680429 ·Status: COMPLETED ·Phase: PHASE1
-
Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects
NCT02871037 ·Status: COMPLETED ·Phase: PHASE1