Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects

Cao Yu

Status and phase: Unknown; Phase 1

Conditions: Therapeutic Equivalency

Treatments: Drug: Extended Release Nifedipine Tablets 30 mg; Drug: Extended Release Nifedipine Tablets 30 mg (Adalat® GITS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04438720

Awk-2019-BE-03

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Extended Release Nifedipine Tablets（Adalat® GITS）

Active Comparator group

Description:

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

Treatment:

Drug: Extended Release Nifedipine Tablets 30 mg (Adalat® GITS)

Extended Release Nifedipine Tablets

Experimental group

Description:

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

Treatment:

Drug: Extended Release Nifedipine Tablets 30 mg