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An Open-label, Single-arm, Sequential study to evaluate the effect of Polyethylene Glycol Loxenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, on the pharmacokinetics and pharmacodynamics of warfarin in Healthy Chinese Volunteers

An Open-label, Single-arm, Sequential study to evaluate the effect of Polyethylene Glycol Loxenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, on the pharmacokinetics and pharmacodynamics of warfarin in Healthy Chinese Volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800015049
Enrollment
Unknown
Registered
2018-03-05
Start date
2015-07-07
Completion date
Unknown
Last updated
2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Interventions

1:In this open-label, single-arm, two-treatment, sequential study, 16 healthy male subjects were administered warfarin (5 mg) alone on day 1. After a washout interval, subjects were Injected subcutane

Sponsors

First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Chinese male volunteers aged 18 to 45 years with body mass index (BMI) between 19 and 25 kg/m2 were eligible for participation. Each volunteer was required to provide written informed consent for participation before the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria included known hypersensitivity to any ingredient in this formulation the presence of heart, kidney, neurologic, or metabolic disease; any acute or chronic disease; and the use of other drugs within 14 days before or during the trial.

Design outcomes

Primary

MeasureTime frame
Cmax;Tmax;AUC0-t;AUC0-8;INR;—

Countries

China

Contacts

Public ContactShentu Jianzhong

First Affiliated Hospital,College of Medicine, Zhejiang University

tjz@zju.edu.cn+86 0571-87236560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026