To Evaluate the Effect of Food on the Pharmacokinetics of Y-4 Tablets in Healthy Subjects

Recruiting Phase 1 Interventional Study
Healthy Male and Female Subjects
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 – 45
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Beijing Tiantan Hospital · Other
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About This Trial

Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole. The objective is to assess the effect of food on the pharmacokinetics (PK) of pregabalin and riluzole in healthy adult subjects after a single oral dose of Y-4 tablets.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Healthy adult male and female subjects, 18-45 years of age (including both ends). 2. Body weight ≥ 50 kg for male and ≥ 45 kg for female, body mass index (BMI) within the range of 19 - 28 kg/m2 (including both ends). 3. During the screening period, serum creatinine is within …
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Ya Shu Li, Doctor

+010-59978555

shuyali85@163.com

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