Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects

Healthy Subjects Clinical Trial

Official title:

Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411875
• Other study ID #: 180815-ALDP-01
• Status: Completed
• Phase: Phase 1
• Start date: November 13, 2018
• Est. completion date: February 15, 2019

Study information

• Verified date: May 2020
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The single-dose randomized, open-label, two-period crossover study was executed in the Phase I Clinical Research Center of the Affiliated Hospital of Qingdao University. According to the random table generate by SAS 9.4, the subjects were divided into two groups at the ratio of 1:1. The select qualified volunteers were hospitalized in the Phase I Clinical Research Center, and fasted for 10 hours overnight until administration. The medicine was swallowed with 240 ml water at room temperature. Blood samples were taken before administration and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after administration. The samples were centrifuged at 1,800 g for 10 min at 4 °C to separate the plasma. The plasma samples were divided into two aliquots and stored at -80 °C until bioanalysis. The half-life of levamlodipine is 30 ~ 50 hours. Washout period, the interval between two administration, is 21 days. In the two periods, the operation was kept the same.

Moreover, in high fat meal group, the high-fat breakfast was arranged within half an hour before taking the medicine. Other procedures were the same as those in the fasting group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 48 Years

Eligibility

Inclusion Criteria:

• Healthy male or female aged 18 and above.

• 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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Amlodipine 10 mg
The subjects randomly received single oral administration of amlodipine 10 mg.
• Levamlodipine 5 mg
The subjects randomly received single oral administration of levamlodipine 5 mg.

Locations

Country	Name	City	State
China	Phase ? Clinical Research Center	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	64 days
Primary	Area under the plasma concentration versus time curve (AUC)0-t	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t	64 days
Primary	Area under the plasma concentration versus time curve (AUC)0-8	Evaluation of Area under the plasma concentration versus time curve (AUC)0-8	64 days
Secondary	Incidence of Treatment-Emergent Adverse Events	Collection of adverse events	64 days
Secondary	Incidence of abnormal blood pressure	Monitor both systolic and diastolic blood pressure	64 days
Secondary	Incidence of abnormal temperature	Monitor the temperature	64 days
Secondary	Incidence of abnormal pulse	Temperature the pulse	64 days
Secondary	Incidence of abnormal electrocardiogram waveform	Electrocardiogram inspection	64 days