Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-01-05 @ 12:49 PM
Study NCT ID:
NCT04467060
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2020-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
Sponsor:
Sihuan Pharmaceutical Holdings Group Ltd.
Organization:
Study Overview
Official Title:
A Single-center, Randomized, Double-blinded, Placebo Parallel Controlled Phase 1 Study to Evaluate the Safety and Pharmacology of Single Ascending Dose Administration of Anaprazole in Healthy Chinese Subjects
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: