Hypertension Clinical Trial
Official title:
Randomized Open-label Single-Dose Two-Way Crossover Study to Assess the Relative Bioavailability of 5mg Levamlodipine Tablet vs. 10mg Amlodipine Besylate Tablet in Healthy Subjects Followed by a Phase to Study Food Effect on the PK of Levamlodipine
Verified date | September 2018 |
Source | Conjupro Biotherapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | September 6, 2018 |
Est. primary completion date | September 6, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Collaborative Neuroscience Network, LLC | Long Beach | California |
Lead Sponsor | Collaborator |
---|---|
Conjupro Biotherapeutics, Inc. | CSPC Ouyi Pharmaceutical Co., Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The plasma concentration of study drugs | Plasma concentration of study drugs will be measured at all the time points. | 6 weeks |
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