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Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03657550
Recruitment Status : Completed
First Posted : September 5, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
CSPC Ouyi Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Conjupro Biotherapeutics

Brief Summary:
This study are (1) to assess the relative bioavailability (BA) of a single oral dose of either 5 mg of Levamlodipine Maleate Tablets from CSPC or 10 mg of Amlodipine Besylate Tablet (NORVASC®) from Pfizer Inc. under fasting condition in male and female healthy subjects; and (2) to evaluate food effect on the PK profile of Levamlodipine Maleate Tablets from CSPC.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Levamlodipine Malate Tablets Drug: Amlodipine Besylate Tablets Phase 1

Detailed Description:

This study consists of 2 parts:

Part 1 will be a randomized, open-label, single-dose, two-way crossover study to assess the relative BA of levamlodipine maleate tablets from CSPC (Test) versus Amlodipine Besylate Tablet NORVASC® from Pfizer Inc. (Reference) after a single oral administration under fasted conditions in male and female healthy subjects. Approximately 32 healthy subjects will be enrolled in the US to obtain 27 completed subjects.

Part 2 will be a single-arm, open-label, single-dose phase to assess food effect on the PK profile of levamlodipine maleate tablets from CSPC. Subjects who have completed Part 1 will be rolled over to Part 2 after a wash-out period for at least 14-days since the last dosing. Subjects will receive a single oral administration of study drug under a high-fat / high-calorie meal that should derive approximately 150, 250 and 500-600 calories from protein, carbohydrate and fat, respectively.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This study consists of 2 parts. Part 1 will be a randomized, open-label, single-dose, two-way crossover study to assess the relative BA of levamlodipine maleate tablets from CSPC versus Amlodipine Besylate Tablet NORVASC® from Pfizer Inc. after a single oral administration under fasted conditions in male and female healthy subjects. Part 2 will be a single-arm, open-label, single-dose phase to assess food effect on the PK profile of levamlodipine maleate tablets from CSPC. Subjects who have completed Part 1 will be rolled over to Part 2 after a wash-out period for at least 14-days since the last dosing. Subjects will receive a single oral administration of study drug under a high-fat / high-calorie meal that should derive approximately 150, 250 and 500-600 calories from protein, carbohydrate and fat, respectively.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Single-Dose, Two-Way Crossover Study to Assess the Relative Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet (NORVASC® From Pfizer Inc.) in Healthy Subjects Followed by a Phase to Study Food Effect on the PK Profile of Levamlodipine
Actual Study Start Date : May 31, 2018
Actual Primary Completion Date : September 6, 2018
Actual Study Completion Date : September 6, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1 Period 1
Levamlodipine Malate Tablets (test drug, 5mg) or Amlodipine Besylate Tablets (NORVASC®, reference drug, 10mg) administered as a single oral dose.
Drug: Levamlodipine Malate Tablets
5mg of Levamlodipine Malate Tablet
Other Name: Xuanning®

Drug: Amlodipine Besylate Tablets
5mg of Levamlodipine Malate Tablet
Other Name: NORVASC®

Experimental: Part 1 Period 2
Levamlodipine Maleate Tablets (test drug, 5mg) or Amlodipine Besylate Tablets (NORVASC®, reference drug, 10mg) administered as a single oral dose, alternative from what same subjects received from Period 1, under fasted conditions
Drug: Levamlodipine Malate Tablets
5mg of Levamlodipine Malate Tablet
Other Name: Xuanning®

Drug: Amlodipine Besylate Tablets
5mg of Levamlodipine Malate Tablet
Other Name: NORVASC®

Experimental: Part 2 Food Effect
Levamlodipine Malate Tablets (test drug, 5mg) administered as a single oral dose under a high-fat / high-calorie meal
Drug: Levamlodipine Malate Tablets
5mg of Levamlodipine Malate Tablet
Other Name: Xuanning®

Drug: Amlodipine Besylate Tablets
5mg of Levamlodipine Malate Tablet
Other Name: NORVASC®




Primary Outcome Measures :
  1. The plasma concentration of study drugs [ Time Frame: 6 weeks ]
    Plasma concentration of study drugs will be measured at all the time points.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  1. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and be practicing a medically acceptable method of contraception with an annual failure rate of less than 1% during the study and 60 days after discontinuation of study treatment.
  2. Considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs;
  3. Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before screening;
  4. Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg;

Exclusion Criteria:

  1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
  2. Mean systolic blood pressure of three measurements >140 mmHg, or a mean diastolic blood pressure of three measurements >90 mmHg at screening.
  3. Known or suspected malignancy;
  4. Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV);
  5. A history of seizure. However, a history of febrile seizure is allowed;
  6. Positive pregnancy test result, or plan to become pregnant if female;
  7. A hospital admission or major surgery within 30 days prior to screening;
  8. Participation in any other investigational drug trial within 30 days prior to screening;
  9. DSM-V substance use disorder within 6 months prior to screening;
  10. A positive result for alcohol or drugs of abuse at screening or admission;
  11. Tobacco use within 6 months prior to screening;
  12. An unwillingness or inability to comply with food and beverage restrictions during study participation;
  13. Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to screening;
  14. Use of prescription or over-the-counter (OTC) medications, and herbal medicines (including St John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing;
  15. A history of suicide attempt in the past 12 months and/or seen by the investigator as having a significant history of risk of suicide or homicide;
  16. A history of intolerance or hypersensitivity to amlodipine or any excipients;
  17. An unwillingness of male participants to use appropriate contraceptive measures if engaging in sex intercourse with a female partner of childbearing potential during the study and 60 days after discontinuation of study treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657550


Locations
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United States, California
Collaborative Neuroscience Network, LLC
Long Beach, California, United States, 90806
Sponsors and Collaborators
Conjupro Biotherapeutics
CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators
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Study Director: Ronald Walls, MD CSPC Conjupro

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Responsible Party: Conjupro Biotherapeutics
ClinicalTrials.gov Identifier: NCT03657550     History of Changes
Other Study ID Numbers: LAM-US-101
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Niacin
Amlodipine
Maleic acid
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Enzyme Inhibitors
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances