Therapeutic Equivalency
Conditions
Keywords
Extended Release Nifedipine Tablets
Brief 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.
Interventions
DRUGExtended Release Nifedipine Tablets 30 mg
The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.
DRUGExtended Release Nifedipine Tablets 30 mg (Adalat® GITS)
The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.
Sponsors
Cao Yu
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 60 days | Evaluation of Peak Plasma Concentration (Cmax) |
| Area under the plasma concentration versus time curve (AUC)0-t | 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-∞ | 60 days | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 60 days | Collection of adverse events |
| Incidence of abnormal blood pressure | 60 days | Monitor both systolic and diastolic blood pressure |
| Incidence of abnormal electrocardiogram waveform | 60 days | Electrocardiogram inspection |
| Incidence of abnormal temperature | 60 days | Monitor the temperature |
| Incidence of abnormal pulse | 60 days | Temperature the pulse |
Countries
China
Contacts
Primary ContactYu Cao
Outcome results
None listed