Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04505787
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2020-07-13
Brief Title:
S-flurbiprofen Bioavailability Trial to Compare a Newly Developed Patch vs a Marketed Tablet
Sponsor:
SocraTec RD GmbH
Organization:
SocraTec RD GmbH
Study Overview
Official Title:
Characterisation of Relative Bioavailability of a Newly Developed S-flurbiprofen Containing Patch Formulation in Comparison With a Marketed Oral Flurbiprofen Containing Tablet Formulation - a Multiple Dose Randomised 2-period Crossover
Status:
COMPLETED
Status Verified Date:
2020-10
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:
Teikoku Seiyaku Co Ltd Japan is developing a new Esflurbiprofen Hydrogel Patch EFHP a transdermal product containing 165 mg of the S-enantiomer of flurbiprofen S-flurbiprofen as its active pharmaceutical ingredient
The present clinical trial will be conducted to characterise maximum observed systemic exposure of the newly developed EFHP Test vs Froben 100 mg Reference containing 100 mg racemic flurbiprofen in a 11 ratio Characterisation will be performed under steady state conditions in order to bridge the available safety information on the basis of the comparison of maximum observed systemic exposure by means of AUC0-24hssP vs AUC0-24ssT and CmaxssP vs CmaxssT of S-flurbiprofen
The present clinical trial will be conducted to characterise maximum observed systemic exposure of the newly developed EFHP Test vs Froben 100 mg Reference containing 100 mg racemic flurbiprofen in a 11 ratio Characterisation will be performed under steady state conditions in order to bridge the available safety information on the basis of the comparison of maximum observed systemic exposure by means of AUC0-24hssP vs AUC0-24ssT and CmaxssP vs CmaxssT of S-flurbiprofen
Detailed Description:
This single centre open-label randomised order of treatments balanced multiple dose trial will be performed in a 2-period 2-sequence-crossover design
The Test Product patch will be applied once daily over 14 consecutive days whereby each patch will remain applied for 24 h Blood sampling will be performed after the 1st patch application over 24 h in order to characterise the single dose application and after the 14th patch application over 72 h in order to characterise pharmacokinetic parameters after multiple dosing including elimination phase In between through values will be taken in the morning of specified study days to characterise steady-state built-up phase
The Reference product will be administered after a light meal as single oral doses of 100 mg flurbiprofen three times daily ie every 8 h over 4 days Blood sampling will be performed after the 10th tablet administration over 72 h in order to characterise pharmacokinetic parameters after multiple dosing including elimination phase In between through values will be taken in the morning of study days 1 to 4 to characterise steady-state built-up phase
The clinical trial will be performed as a cross-over investigation with intra-individual comparison thus reducing variability of the pharmacokinetic parameters which is supposed to be higher between subjects than within an individual subject
The Test Product patch will be applied once daily over 14 consecutive days whereby each patch will remain applied for 24 h Blood sampling will be performed after the 1st patch application over 24 h in order to characterise the single dose application and after the 14th patch application over 72 h in order to characterise pharmacokinetic parameters after multiple dosing including elimination phase In between through values will be taken in the morning of specified study days to characterise steady-state built-up phase
The Reference product will be administered after a light meal as single oral doses of 100 mg flurbiprofen three times daily ie every 8 h over 4 days Blood sampling will be performed after the 10th tablet administration over 72 h in order to characterise pharmacokinetic parameters after multiple dosing including elimination phase In between through values will be taken in the morning of study days 1 to 4 to characterise steady-state built-up phase
The clinical trial will be performed as a cross-over investigation with intra-individual comparison thus reducing variability of the pharmacokinetic parameters which is supposed to be higher between subjects than within an individual subject
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TK-254R-0101 | OTHER | Client protocol number Teikoku Seiyaku Co | None |
| 2019-003918-14 | EUDRACT_NUMBER | None | None |