Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-25

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Therapeutic Equivalency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Extended Release Nifedipine Tablets（Adalat® GITS）

Extended Release Nifedipine reference formulation at a single dose of 30 mg

Group Type ACTIVE_COMPARATOR

Extended Release Nifedipine Tablets 30 mg (Adalat® GITS)

Intervention Type DRUG

The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.

Extended Release Nifedipine Tablets

Extended Release Nifedipine test formulation at a single dose of 30 mg

Group Type EXPERIMENTAL

Extended Release Nifedipine Tablets 30 mg

Intervention Type DRUG

The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.

Interventions

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Extended Release Nifedipine Tablets 30 mg

The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.

Intervention Type DRUG

Extended Release Nifedipine Tablets 30 mg (Adalat® GITS)

The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.

Intervention Type DRUG

Eligibility Criteria

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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.