Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects

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

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.

Study Overview

• Status: Unknown
• Conditions: Therapeutic Equivalency
• Intervention / Treatment: Drug: Extended Release Nifedipine Tablets 30 mg (Adalat® GITS); Drug: Extended Release Nifedipine Tablets 30 mg

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yu Cao; Phone Number: +86 18661809090; Email: caoyu1767@126.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266003
      • Recruiting
      • Phase I Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Extended Release Nifedipine Tablets（Adalat® GITS）; Extended Release Nifedipine reference formulation at a single dose of 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.
Experimental: Extended Release Nifedipine Tablets; Extended Release Nifedipine test formulation at a single dose of 30 mg	Drug: Extended Release Nifedipine Tablets 30 mg; The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cao Yu

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Anticipated): September 9, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Extended Release Nifedipine Tablets
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Nifedipine
• Other Study ID Numbers: Awk-2019-BE-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No