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An Bioequivalence Study to Compare 10mg & 20mg of Senaparib Capsules in Healthy Chinese Subjects Under Fasting Condition

NCT07019194 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-13

No results posted yet for this study

Summary

An Open-label, Randomized, Single-dose, Two-way Crossover Bioequivalence Study to Compare Two Strengths (10 mg and 20 mg) of Senaparib Capsules in Healthy Chinese Subjects Following Oral Administration Under Fasting Condition

Conditions

Interventions

DRUG

Senaparib capsules(20mg)

Single oral dose of Senaparib administered under fasting condition, 1\*20mg capsules in first intervention period and then 2\*10mg capsules in second intervention period (after washout period: at least 5 days)

DRUG

Senaparib capsules(10mg)

Single oral dose of Senaparib administered under fasting condition, 2\*10mg capsules in first intervention period and then 1\*20mg capsules in second intervention period (after washout period: at least 5 days)

Sponsors & Collaborators

  • Impact Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Chaolin Huang · Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-21
Primary Completion
2024-07-15
Completion
2024-07-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07019194 on ClinicalTrials.gov