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

NCT01346657 | Completed Phase 4

• 1 other identifier: 98030
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Nifidipine; red yeast rice; drug-drug interaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The incidence rate of adverse event

  1 week

Study Arms (1)

Nifidipine & LipoCol

EXPERIMENTAL

The effect of LipoCol Forte® capsules on the pharmacokinetics of nifedipine after administering single-dose combination in healthy subjects

Drug: Nifidipine & LipoCol

Interventions

Nifidipine & LipoCol DRUG

The effect of LipoCol Forte® capsules on the pharmacokinetics of nifedipine after administering single-dose combination in healthy subjects.

Nifidipine & LipoCol

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University - WanFang Hospital

Taipei, Taiwan

Location

Study Officials

• Yuh-Mou Sue, M.D. Ph.D.

  Taipei Medical University WanFang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: May 3, 2011
• Study Start: July 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 3, 2011

Record last verified: 2011-05

Locations

TW (1)