Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects

Overview

According to the relevant provisions of bioequivalence test, nifedipine sustained-release tablets (test preparation, t, 30mg / tablet) provided by Guangzhou bostao controlled release pharmaceutical Co., Ltd. were compared with Adalat ® GITS (reference preparation, R, 30mg / tablet) produced by Bayer Pharma AG to evaluate the bioequivalence of single dose in healthy subjects under fasting conditions.

Full Title of Study: “Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 9, 2020

Interventions

  • Drug: Extended Release Nifedipine Tablets 30 mg
    • The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.
  • Drug: Extended Release Nifedipine Tablets 30 mg (Adalat® GITS)
    • The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.

Arms, Groups and Cohorts

  • Active Comparator: Extended Release Nifedipine Tablets(Adalat® GITS)
    • Extended Release Nifedipine reference formulation at a single dose of 30 mg
  • Experimental: Extended Release Nifedipine Tablets
    • Extended Release Nifedipine test formulation at a single dose of 30 mg

Clinical Trial Outcome Measures

Primary Measures

  • Peak Plasma Concentration (Cmax)
    • Time Frame: 60 days
    • Evaluation of Peak Plasma Concentration (Cmax)
  • Area under the plasma concentration versus time curve (AUC)0-t
    • Time Frame: 60 days
    • Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
  • Area under the plasma concentration versus time curve (AUC)0-∞
    • Time Frame: 60 days
    • Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞

Secondary Measures

  • Incidence of Treatment-Emergent Adverse Events
    • Time Frame: 60 days
    • Collection of adverse events
  • Incidence of abnormal blood pressure
    • Time Frame: 60 days
    • Monitor both systolic and diastolic blood pressure
  • Incidence of abnormal temperature
    • Time Frame: 60 days
    • Monitor the temperature
  • Incidence of abnormal pulse
    • Time Frame: 60 days
    • Temperature the pulse
  • Incidence of abnormal electrocardiogram waveform
    • Time Frame: 60 days
    • Electrocardiogram inspection

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy male or female aged 18-45. – The body mass index is in the range of 18.6-28.5 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg. – The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test. – The subjects have no family planning within 3 months and could select contraceptive method. – Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily. Exclusion Criteria:

  • Being allergy to the study medications, smoking, alcohol abuse. – Participation in another clinical trial within 3 months.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cao Yu
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Cao Yu, Director, Head of Phase I clinical research center, Principal Investigator, Clinical Professor. – The Affiliated Hospital of Qingdao University
  • Overall Contact(s)
    • Yu Cao, +86 18661809090, caoyu1767@126.com

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