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Completed

NCT Number: NCT04411875

Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects

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.

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Key information

Conditions

Healthy Subjects

Age range

19 year–48 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phase Ⅰ Clinical Research Center

Qingdao, Shandong, 266003, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amlodipine 10 mg

Drug

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

Levamlodipine 5 mg

Drug

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

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: 64 days

    Evaluation of Peak Plasma Concentration (Cmax)

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

    Time frame: 64 days

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

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

    Time frame: 64 days

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

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: 64 days

    Collection of adverse events

  2. Incidence of abnormal blood pressure

    Time frame: 64 days

    Monitor both systolic and diastolic blood pressure

  3. Incidence of abnormal temperature

    Time frame: 64 days

    Monitor the temperature

  4. Incidence of abnormal pulse

    Time frame: 64 days

    Temperature the pulse

  5. Incidence of abnormal electrocardiogram waveform

    Time frame: 64 days

    Electrocardiogram inspection

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 2, 2020
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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