MedTrace Logo

An Comparative Pharmacokinetic Study of Amlodipine Besylate Controlled-release Tablets,China in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions

NCT05667818 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-01-04

No results posted yet for this study

Summary

Amlodipine Besylate Controlled-release Tablets in Healthy Volunteers in a Randomized, Open, Two-cycle, Double-cross, Fasting State Comparative Pharmacokinetic Study.

Major objective:

Taking amlodipine besylate controlled-release tablets (specification: 5 mg) developed by Overseas Pharmaceuticals, Ltd. as the test preparation and amlodipine besylate tablets (trade name: Luohuoxi, specification: 5 mg) produced by Pfizer Inc. as the control preparation, the pharmacokinetics parameters of the single oral administration test preparation and the control preparation in China healthy volunteers were investigated and compared in an fasting state.

Secondary objective:

To evaluate the safety of single oral administration of test preparation and control preparation in China healthy volunteers on an empty stomach.

Conditions

Interventions

DRUG

Amlodipine besylate tablets (trade name: Norfloxacin ®）

Specification: 5 mg Batch No.: FX3445 Content: 100.2% Expiry date: January 2027 Storage conditions: dark and sealed Manufacturer: Pfizer Inc. Provider: Overseas Pharmaceuticals, Ltd. Take one tablet once a day.

DRUG

Amlodipine besylate controlled-release tablets

Test preparation (T): amlodipine besylate controlled-release tablets Specification: 5 mg Batch No.: 22102501 Content: 100.9% Expiry date: October 24, 2024 Storage conditions: dark, sealed at room temperature. Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Overseas Pharmaceuticals, Ltd. Take one tablet once a day.

Sponsors & Collaborators

  • Guangzhou Health Start Pharmaceutical Techology Co.,Ltd

    collaborator UNKNOWN

  • Overseas Pharmaceuticals, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-28
Primary Completion
2023-02-28
Completion
2023-03-10
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05667818 on ClinicalTrials.gov