A Phase 1 interventional study of Anaprazole Sodium and Placebo in Healthy Male Volunteers, sponsored by Sihuan Pharmaceutical Holdings Group Ltd.. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-10.
Sponsored by Sihuan Pharmaceutical Holdings Group Ltd. · Phase 1, Interventional, and Treatment
A single-center, randomized, open-labeled, 2×2 crossover phase 1 study to evaluate the pharmakinetics effect of high fat food to single dose administration of Anaprazole in healthy Chinese male subjects. 14 health male subjects is divided to A group (n=7) and B group (n=7). 2 periods (7 days) cross-over design, anaprazole 40mg single dose, one is fasting oral administration before breakfast, the other is oral administration 30 minutes after breakfast with high fat food.
Sihuan Pharmaceutical Holdings Group Ltd. is the lead sponsor of 23 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single ascendinng dose (2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg), fasting oral administration.
Drug: Anaprazole Sodium
single dose, fasting oral administration
Drug: Placebo
2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg,fasting oral administration.
single dose, fasting oral administration
Number of subjects with adverse events and serious adverse events as assessed by CTCAE v5.0
All adverse events will be monitored in each subject
Time frame: From signing informed consent to study completion, 8 days post-dose
No study locations are listed for this record.
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Sihuan Pharmaceutical Holdings Group Ltd.