Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00955760
Status:
COMPLETED
Last Update Posted:
2011-02-08
First Post:
2009-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Analyzing the Effect of Rifampicin Administration on the Pharmacokinetics of Neramexane Mesylate
Sponsor:
Merz Pharmaceuticals GmbH
Organization:
Study Overview
Official Title:
A Single Center, Open-Label, Three Periods, Fixed Sequence Design Study Analyzing the Effect of Rifampicin Administration on the Pharmacokinetics of Neramexane Mesylate
Status:
COMPLETED
Status Verified Date:
2009-08
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 Objectives:
• Assess the effects of poly-specific cytochrome P450 and drug-transporter induction by repeated dose Rifampicin (600 mg/day) co-administration on the single-dose pharmacokinetics of Neramexane.
Secondary Objectives:
• To assess safety and tolerability of Neramexane single dose treatment alone and co-administration of a Neramexane single dose with a Rifampicin repeated dose treatment.
• Assess the effects of poly-specific cytochrome P450 and drug-transporter induction by repeated dose Rifampicin (600 mg/day) co-administration on the single-dose pharmacokinetics of Neramexane.
Secondary Objectives:
• To assess safety and tolerability of Neramexane single dose treatment alone and co-administration of a Neramexane single dose with a Rifampicin repeated dose treatment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: