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Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects

NCT04438720 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-08-21

No results posted yet for this study

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

  • Therapeutic Equivalency

Interventions

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.

Sponsors & Collaborators

  • Cao Yu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2020-09-09
Completion
2020-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04438720 on ClinicalTrials.gov