Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342804
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-11
Brief Title:
Food Effect on the Bioavailability of 4-MUST Tablets 128 mg
Sponsor:
Valenta Pharm JSC
Organization:
Valenta Pharm JSC
Study Overview
Official Title:
An Open-label Crossover Study With 2 Treatments Fasting and Fed Conditions 2 Periods 2 Sequences to Evaluate the Effect of Food Intake on the Bioavailability of 4-MUST Tablets 128 mg at a Single Dose of 256 mg in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Primary objective of the study evaluation of the effect of food intake on the bioavailability of 4-MUST tablets 128 mg Valenta Pharm JSC after a single oral administration on an empty stomach and after a meal at a dose of 256 mg two tablets
Additional aim of the study evaluation of pharmacokinetic parameters safety and tolerability of 4-MUST tablets 128 mg Valenta Pharm JSC in healthy volunteers after a single oral administration on an empty stomach and after a meal at a dose of 256 mg two tablets
Additional aim of the study evaluation of pharmacokinetic parameters safety and tolerability of 4-MUST tablets 128 mg Valenta Pharm JSC in healthy volunteers after a single oral administration on an empty stomach and after a meal at a dose of 256 mg two tablets
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?:
None