Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects

Therapeutic Equivalency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04438720
• Other study ID #: Awk-2019-BE-03
• Status: Recruiting
• Phase: Phase 1
• Start date: June 25, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: August 2020
• Source: The Affiliated Hospital of Qingdao University
• Contact: Yu Cao
• Phone: +86 18661809090
• Email: caoyu1767[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2020
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Therapeutic Equivalency

Intervention

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

Locations

Country	Name	City	State
China	Phase I Clinical Research Center	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Cao Yu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	60 days
Primary	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
Primary	Area under the plasma concentration versus time curve (AUC)0-8	Evaluation of Area under the plasma concentration versus time curve (AUC)0-8	60 days
Secondary	Incidence of Treatment-Emergent Adverse Events	Collection of adverse events	60 days
Secondary	Incidence of abnormal blood pressure	Monitor both systolic and diastolic blood pressure	60 days
Secondary	Incidence of abnormal temperature	Monitor the temperature	60 days
Secondary	Incidence of abnormal pulse	Temperature the pulse	60 days
Secondary	Incidence of abnormal electrocardiogram waveform	Electrocardiogram inspection	60 days