Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT00176020
Status:
UNKNOWN
Last Update Posted:
2006-03-15
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nicotinic Acid - Pharmacokinetics, Pharmacodynamics, Receptor Expression
Sponsor:
Heidelberg University
Organization:
Study Overview
Official Title:
Double-Blind, Randomized, Placebo-Controlled, Single-Center, 2 Treatment, 3-Way Crossover Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of a Single Oral Repeated Dose of 500 Mg Nicotinic Acid as Tablets in Healthy Subjects
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
NOT_YET_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:
The study will be a double-blind, randomized, placebo-controlled, single-center, 2 treatment, 3--way crossover. Subjects will be randomly allocated to a treatment sequence - AAB, ABA or BAA. The two treatments will be:
* Treatment A: 500 mg nicotinic acid (Niacor(R))
* Treatment B: Niacor(R) Placebo
Each trial period will last one day, there will be a wash-out period of at least 2 days between each trial period. Five to seven days after study day 1 of trial period 3 there will be a final safety examination.
* Treatment A: 500 mg nicotinic acid (Niacor(R))
* Treatment B: Niacor(R) Placebo
Each trial period will last one day, there will be a wash-out period of at least 2 days between each trial period. Five to seven days after study day 1 of trial period 3 there will be a final safety examination.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K115 | None | None | View |