A Study of BGM0504 Tablets in Healthy Chinese Subjects

Recruiting Phase 1 Interventional Study
Chinese Healthy Volunteers
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
144 (estimated)
Sponsor
BrightGene Bio-Medical Technology Co., Ltd. · Industry
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About This Trial

A randomized, open-label, multiple-dose study to evaluate the effects of high-fat meals and different administration conditions (including water intake and fasting time) on the pharmacokinetics of BGM0504 tablets at a dose of 20mg in healthy Chinese participants and to assess its safety and tolerability.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * ○ Between the ages of 18 and 55 years (inclusive) at the time of screening, both male and female; * weight ≥ 50 kg, and body mass index (BMI): 24.0 kg/m² ≤ BMI \< 30 kg/m²(BMI = weight/height²); * (Medical Inquiry) Have a stable body weight (\<5% self-reported change duri…
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