Clinical trial NCT04411875: Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects
Official title: Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: levamlodipine
bioequivalence
pharmacokinetics
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 64 days
measure: Area under the plasma concentration versus time curve (AUC)0-t
timeFrame: 64 days
measure: Area under the plasma concentration versus time curve (AUC)0-∞
timeFrame: 64 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 64 days
measure: Incidence of abnormal blood pressure
timeFrame: 64 days
measure: Incidence of abnormal temperature
timeFrame: 64 days
measure: Incidence of abnormal pulse
timeFrame: 64 days
measure: Incidence of abnormal electrocardiogram waveform
timeFrame: 64 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Phase Ⅰ Clinical Research Center
state: Shandong
Study officials:
affiliation: the study director of phase I clinical research center
name: yu Cao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.