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Comparative Fasting Bioavailability of Two Everolimus Formulations in Healthy Male Chinese Volunteers: An Open-Label, Randomized, Single-Dose, Two-Way Crossover Study

Comparative Fasting Bioavailability of Two Everolimus Formulations in Healthy Male Chinese Volunteers: An Open-Label, Randomized, Single-Dose, Two-Way Crossover Study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-14005691
Enrollment
Unknown
Registered
2014-11-12
Start date
2014-11-12
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Healthy Volunteers

Interventions

Group A:RT(1.5MG)
Group B:TR(1.5mg each period)

Sponsors

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

Eligibility

Sex/Gender
Male
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Chinese volunteers aged 18 to 40 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 tablet; 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;AUC0-t;AUC0-infinity;Tmax;

Countries

China

Contacts

Public ContactShentu Jianzhong
stjz@zju.edu.cn+86 0571-87236560

Outcome results

None listed

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