Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects
Completed · Phase 1
Conditions studied: Hypertension
In brief
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.
Key facts
- Study ID
- NCT03657550
- Run by
- Conjupro Biotherapeutics, Inc.
- People needed
- 36
- Starts
- 2018-05-31
- Expected to finish
- 2018-09-06
- Last updated by the study team
- 2021-09-16
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
- Mean systolic blood pressure of three measurements >140 mmHg, or a mean diastolic blood pressure of three measurements >90 mmHg at screening.
- Known or suspected malignancy;
- Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV);
- A history of seizure. However, a history of febrile seizure is allowed;
- Positive pregnancy test result, or plan to become pregnant if female;
- A hospital admission or major surgery within 30 days prior to screening;
- Participation in any other investigational drug trial within 30 days prior to screening;
- DSM-V substance use disorder within 6 months prior to screening;
- A positive result for alcohol or drugs of abuse at screening or admission;
- Tobacco use within 6 months prior to screening;
- An unwillingness or inability to comply with food and beverage restrictions during study participation;
- 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;
- 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;
- 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;
- A history of intolerance or hypersensitivity to amlodipine or any excipients;
- 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.
Where it is running
- Collaborative Neuroscience Network, LLC — Long Beach, California, United States
Full record on ClinicalTrials.gov
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