The Effect of LipoCol Forte® Capsules on the Pharmacokinetics of Nifedipine After Administering Single-dose Combination to Healthy Subjects - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: Nifidipine & LipoCol	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Effect of LipoCol Forte® Capsules on the Pharmacokinetics of Nifedipine After Administering Single-dose Combination to Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Nifedipine

U.S. FDA Resources

Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:

Evaluation of the pharmacokinetic parameters of nifedipine in healthy subjects [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Plasma concentrations of nifedipine were detected at following time: (Pre-dose (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 oral administration nifedipine capsule with or without red yeast rice capsule (LipoCol)) All pharmacokinetic parameters were determined with nifedipine concentrations by non-compartment methods.

Secondary Outcome Measures:

The incidence rate of adverse event [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
The incidence rate of adverse event

Enrollment:	14
Study Start Date:	July 2009
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Nifidipine & LipoCol The effect of LipoCol Forte® capsules on the pharmacokinetics of nifedipine after administering single-dose combination in healthy subjects	Drug: Nifidipine & LipoCol The effect of LipoCol Forte® capsules on the pharmacokinetics of nifedipine after administering single-dose combination in healthy subjects.

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.

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects must be at the age of 20-40 years old and in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
Vital signs (after 3 minutes resting in a upright position) which are within the following ranges:Ear body temperature between 35.0-37.5 degree celsius (°C). Systolic blood pressure, 90-140 millimeters of mercury (mm Hg). Diastolic blood pressure, 50-90 millimeters of mercury (mm Hg). Pulse rate, 50-90 beats per minute (bpm). Fasting blood glucose, < 110 milligrams per deciliter (mg/dL).
Body weight must be above 50 kilograms (kg) and within -20 to +20% of ideal body weight.
Able to sign informed consent prior to study.
Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion Criteria:

Use of any prescription medication within 14 days prior to dosing.
Use of over-the-counter medications or vitamins within 14 days prior to dosing.
Significant illness within 2 weeks prior to dosing.
Participation in any clinical investigation within 2 months prior to dosing or longer than required by local regulation.
Donate or loss more than 500 milliliter(mL) of blood within 3 months prior to dosing.
Presence of cardiovascular disease.
Presence of gastrointestinal disease.
Presence of asthma or lung disease.
Presence of liver disease, hepatitis B, hepatitis C or liver injury as indicated by an abnormal liver function profile.
Presence of impaired renal function.
Presence of neurological disease.
Presence of psychiatrical disease.
Subject is known for HIV infected.
A known hypersensitivity to nifedipine, lovastatin and Chinese Red Yeast Rice or their analogs.
History of drug or alcohol abuse within 12 months prior to dosing.
Permanent confinement to an institution.
Individuals are judged by the investigator or pharmacokineticist to be undesirable as subjects for other reasons.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346657

Locations

Taiwan
Taipei Medical University - WanFang Hospital
Taipei, Taiwan

Sponsors and Collaborators

Taipei Medical University WanFang Hospital

Investigators

Principal Investigator:

Yuh-Mou Sue, M.D. Ph.D.

Taipei Medical University WanFang Hospital

More Information

No publications provided

Responsible Party:	Yuh-Mou Sue, Department of Internal Medicine, Wanfang Hospital
ClinicalTrials.gov Identifier:	NCT01346657 History of Changes
Other Study ID Numbers:	98030
Study First Received:	April 27, 2011
Last Updated:	May 1, 2011
Health Authority:	Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:

Nifidipine
red yeast rice
drug-drug interaction

Additional relevant MeSH terms:

Nifedipine
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 21, 2013