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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 21, 2018
First Posted Date  ICMJE September 5, 2018
Last Update Posted Date April 4, 2019
Actual Study Start Date  ICMJE May 31, 2018
Actual Primary Completion Date September 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2018)
The plasma concentration of study drugs [ Time Frame: 6 weeks ]
Plasma concentration of study drugs will be measured at all the time points.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03657550 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Levamlodipine Malate Tablets
    5mg of Levamlodipine Malate Tablet
    Other Name: Xuanning®
  • Drug: Amlodipine Besylate Tablets
    5mg of Levamlodipine Malate Tablet
    Other Name: NORVASC®
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Levamlodipine Malate Tablets
    • Drug: Amlodipine Besylate Tablets
  • 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
    Interventions:
    • Drug: Levamlodipine Malate Tablets
    • Drug: Amlodipine Besylate Tablets
  • Experimental: Part 2 Food Effect
    Levamlodipine Malate Tablets (test drug, 5mg) administered as a single oral dose under a high-fat / high-calorie meal
    Interventions:
    • Drug: Levamlodipine Malate Tablets
    • Drug: Amlodipine Besylate Tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2018)
36
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2018)
32
Actual Study Completion Date  ICMJE September 6, 2018
Actual Primary Completion Date September 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03657550
Other Study ID Numbers  ICMJE LAM-US-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Conjupro Biotherapeutics
Study Sponsor  ICMJE Conjupro Biotherapeutics
Collaborators  ICMJE CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators  ICMJE
Study Director: Ronald Walls, MD CSPC Conjupro
PRS Account Conjupro Biotherapeutics
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP