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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Nifidipine & LipoCol

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Medical University - WanFang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. 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).
3. Body weight must be above 50 kilograms (kg) and within -20 to +20% of ideal body weight.
4. Able to sign informed consent prior to study.
5. Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the pharmacokinetic parameters of nifedipine in healthy subjects	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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence rate of adverse event	The incidence rate of adverse event	1 week

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Principal Investigator: Yuh-Mou Sue, M.D. Ph.D., Taipei Medical University WanFang Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: May 1, 2011
• First Posted (Estimate): May 3, 2011

Study Record Updates

• Last Update Posted (Estimate): May 3, 2011
• Last Update Submitted That Met QC Criteria: May 1, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: drug-drug interaction; red yeast rice; Nifidipine
• Other Study ID Numbers: 98030