Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects

NCT04411875 | Completed Phase 1 DMC

• 1 other identifier: 180815-ALDP-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Keywords

levamlodipine; bioequivalence; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  Evaluation of Peak Plasma Concentration (Cmax)

  64 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

  64 days

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

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

  64 days

Secondary Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events

  64 days

• Incidence of abnormal blood pressure

  64 days

• Incidence of abnormal temperature

  64 days

• Incidence of abnormal pulse

  64 days

• Incidence of abnormal electrocardiogram waveform

  64 days

Study Arms (2)

Amlodipine

ACTIVE COMPARATOR

amlodipine reference formulation at a single dose of 10 mg

Drug: Amlodipine 10 mg

Levamlodipine

EXPERIMENTAL

levamlodipine test formulation at a single dose of 5 mg

Drug: Levamlodipine 5 mg

Interventions

Amlodipine 10 mg DRUG

The subjects randomly received single oral administration of amlodipine 10 mg.

Amlodipine

Levamlodipine 5 mg DRUG

The subjects randomly received single oral administration of levamlodipine 5 mg.

Levamlodipine

Eligibility Criteria

• Age: 19 Years - 48 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Phase Ⅰ Clinical Research Center

Qingdao, Shandong, 266003, China

Location

Related Publications (1)

• Li X, Wang C, Li T, Liu Y, Liu S, Tao Y, Ma Y, Gao X, Cao Y. Bioequivalence of levamlodipine besylate tablets in healthy Chinese subjects: a single-dose and two-period crossover randomized study. BMC Pharmacol Toxicol. 2020 Nov 19;21(1):80. doi: 10.1186/s40360-020-00459-6.

  PMID: 33213527 DERIVED

MeSH Terms

Interventions

Amlodipine; levamlodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• yu Cao, Doctor

  the study director of phase I clinical research center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 2, 2020
• Study Start: November 13, 2018
• Primary Completion: January 15, 2019
• Study Completion: February 15, 2019
• Last Updated: June 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data have been available on February 15, 2019. The duration has not been determined.

Locations

CN (1)