Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-20 @ 10:12 PM
Study NCT ID:
NCT02252692
Status:
UNKNOWN
Last Update Posted:
2014-09-30
First Post:
2014-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relative Bioavailability Study With Enalapril in Healthy Volunteers
Sponsor:
Ethicare GmbH
Organization:
Study Overview
Official Title:
Relative Bioavailability of Enalapril Administered as Orodispersible Minitablets in Healthy Adults
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Phase I study in healthy adult male and female volunteers to compare the bioavailability of enalapril administered in orodispersible Minitablets with or without water in comparison to the standard galenic tablet formulation of enalapril. The standard pharmacokinetic parameters will be calculated from the bioanalytical results for enalapril and enalaprilat and compared in a descriptive statistical analysis.
Detailed Description:
Trial design: Open label, randomized, 3-way cross-over, 3-treatments, 3-periods in 24 healthy male and female adult subjects.
Primary objectives:
1. To assess the relative bioavailability of 10 mg enalapril administered as orodispersible minitablets (ODMT) with water versus a standard enalapril tablet formulation (reference product: Renitec® 2 x 5 mg tablets) taken with water;
2. To assess the relative bioavailability of 10 mg enalapril administered as orodispersible minitablets (ODMT) dispersed in the oral cavity versus a standard enalapril tablet formulation (reference product: Renitec® 2 x 5 mg tablets) taken with water.
Secondary objectives:
1. To assess whether the PK of enalapril is affected when the orodispersible minitablet (ODMT) is entirely swallowed with water versus dispersion in the oral cavity.
2. To assess the general safety and tolerability including local tolerability and palatability of enalapril administered as orodispersible minitablet (ODMT).
Primary objectives:
1. To assess the relative bioavailability of 10 mg enalapril administered as orodispersible minitablets (ODMT) with water versus a standard enalapril tablet formulation (reference product: Renitec® 2 x 5 mg tablets) taken with water;
2. To assess the relative bioavailability of 10 mg enalapril administered as orodispersible minitablets (ODMT) dispersed in the oral cavity versus a standard enalapril tablet formulation (reference product: Renitec® 2 x 5 mg tablets) taken with water.
Secondary objectives:
1. To assess whether the PK of enalapril is affected when the orodispersible minitablet (ODMT) is entirely swallowed with water versus dispersion in the oral cavity.
2. To assess the general safety and tolerability including local tolerability and palatability of enalapril administered as orodispersible minitablet (ODMT).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: