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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01346657
First Posted: May 3, 2011
Last Update Posted: May 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taipei Medical University WanFang Hospital
  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
Intervention Model: Crossover Assignment
Masking: None (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:


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 ]
    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 ]
    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

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yuh-Mou Sue, Department of Internal Medicine, Wanfang Hospital
ClinicalTrials.gov Identifier: NCT01346657     History of Changes
Other Study ID Numbers: 98030
First Submitted: April 27, 2011
First Posted: May 3, 2011
Last Update Posted: May 3, 2011
Last Verified: May 2011

Keywords provided by Taipei Medical University WanFang Hospital:
Nifidipine
red yeast rice
drug-drug interaction

Additional relevant MeSH terms:
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs