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Relative Bioavailability and Pharmacodynamics of HSK7653 in Healthy Volunteers

NCT06003088 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-08-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2022-08-12
Completion
2022-09-09

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06003088 on ClinicalTrials.gov