NCT04438720

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

June 25, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

June 17, 2020

Last Update Submit

August 20, 2020

Conditions

Therapeutic Equivalency

Keywords

Extended Release Nifedipine Tablets

Outcome Measures

Primary Outcomes (3)

  • Peak Plasma Concentration (Cmax)

    Evaluation of Peak Plasma Concentration (Cmax)

    60 days

  • Area under the plasma concentration versus time curve (AUC)0-t

    Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

    60 days

  • Area under the plasma concentration versus time curve (AUC)0-∞

    Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞

    60 days

Secondary Outcomes (5)

  • Incidence of Treatment-Emergent Adverse Events

    60 days

  • Incidence of abnormal blood pressure

    60 days

  • Incidence of abnormal temperature

    60 days

  • Incidence of abnormal pulse

    60 days

  • Incidence of abnormal electrocardiogram waveform

    60 days

Study Arms (2)

Extended Release Nifedipine Tablets（Adalat® GITS）

ACTIVE COMPARATOR

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

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

Extended Release Nifedipine Tablets

EXPERIMENTAL

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

Drug: Extended Release Nifedipine Tablets 30 mg

Interventions

Extended Release Nifedipine Tablets 30 mgDRUG

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

Extended Release Nifedipine Tablets
Extended Release Nifedipine Tablets 30 mg (Adalat® GITS)DRUG

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

Extended Release Nifedipine Tablets（Adalat® GITS）

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Being allergy to the study medications, smoking, alcohol abuse.
  • Participation in another clinical trial within 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phase I Clinical Research Center

Qingdao, Shandong, 266003, China

RECRUITING

Central Study Contacts

Yu Cao

CONTACT

+86 18661809090caoyu1767@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Head of Phase I clinical research center, Principal Investigator, Clinical Professor.

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 19, 2020

Study Start

June 25, 2020

Primary Completion

September 9, 2020

Study Completion

September 30, 2020

Last Updated

August 21, 2020

Record last verified: 2020-08

Locations

CN(1)