Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 8:16 AM
Study NCT ID:
NCT01346657
Status:
COMPLETED
Last Update Posted:
2011-05-03
First Post:
2011-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of LipoCol Forte® Capsules on the Pharmacokinetics of Nifedipine After Administering Single-dose Combination to Healthy Subjects
Sponsor:
Taipei Medical University WanFang Hospital
Organization:
Study Overview
Official Title:
The Effect of LipoCol Forte® Capsules on the Pharmacokinetics of Nifedipine After Administering Single-dose Combination to Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2011-05
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:
The objective of the study is to evaluate the effect of LipoCol Forte® Capsules on the pharmacokinetics of nifedipine after administering single-dose combination to healthy subjects using a 2x2 crossover design.
Detailed Description:
Healthy subjects were randomly allocated to receive a single dose of either one 5 milgram (mg) nifedipine capsule or one 5 milgram (mg) nifedipine capsule plus one 600 milgram (mg) red yeast rice capsule; after 7-day washout period, they received a single dose of the alternative drug. The subjects were fasted at least 10 hour before dosing. The investigational products were administered with 240 milliliter (mL) of water with the subject in an upright position. The blood samples were collected at prior to the drug administration (T0), and 0.167, 0.333, 0.500, 0.750, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16 and 24 hours after dosing.
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?: