NCT06003088

Relative Bioavailability and Pharmacodynamics of HSK7653 in Healthy Volunteers

A Randomized, Open-label, Two-Way Crossover Study to Evaluate Relative Bioavailability and Pharmacodynamics of Two Doses of HSK7653 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To investigate the relative bioavailability of HSK7653(5mg) given as formulation A versus formulation B. To investigate the relative bioavailability of HSK7653(25mg) given as formulation A versus formulation B. To investigate safety and pharmacodynamics of two doses of HSK7653 in healthy male subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HSK7653(5mg)	Participants will receive a single oral dose of HSK7653(5mg) Formulation A Or a single oral dose of HSK7653(5mg) Formulation B on Day 1 Period 1. Depending on what Formulation was received on Day 1 Period 1, participants will receive either a single oral dose of HSK7653(5mg) Formulation A Or a single oral dose of HSK7653(5mg) Formulation B on Day 1 of Period 2. Each period lasts for 15 days.
DRUG	HSK7653(25mg)	Participants will receive a single oral dose of HSK7653(25mg) Formulation A Or a single oral dose of HSK7653(25mg) Formulation B on Day 1 Period 1. Depending on what Formulation was received on Day 1 Period 1, participants will receive either a single oral dose of HSK7653(25mg) Formulation A Or a single oral dose of HSK7653(25mg) Formulation B on Day 1 of Period 2. Each period lasts for 15 days.

Timeline

• Start date: 2022-06-15
• Primary completion: 2022-08-12
• Completion: 2022-09-09
• First posted: 2023-08-21
• Last updated: 2023-08-24

Locations

1 site across 1 country: China