Trials / Unknown
UnknownNCT04438720
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Cao Yu · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Extended Release Nifedipine Tablets 30 mg | The subjects randomly received single oral administration of extended release nifedipine tablets 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. |
Timeline
- Start date
- 2020-06-25
- Primary completion
- 2020-09-09
- Completion
- 2020-09-30
- First posted
- 2020-06-19
- Last updated
- 2020-08-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04438720. Inclusion in this directory is not an endorsement.