Bioequivalence Study of 4 mg Perindopril Tablets Produced by PT Dexa Medica in Comparison With the Reference Tablets (Prexum® 4 mg, Servier)Under Fasting Condition
Perindopril 4 mg tablets of PT Dexa Medica
+ Perindopril 4 mg tablets of Servier
Treatment Study
Summary
Study start date: September 1, 2008
Actual date on which the first participant was enrolled.The participating subjects were required to have an overnight fast and in the next morning were given orally one tablet of the test drug (Perindopril 4 mg tablets of PT Dexa Medica) or one tablet of the reference drug (Prexum® 4 mg, Servier). Blood samples were drawn immediately before taking the drug (control), and at 20, 40 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 192 hours after drug administration. Three weeks after the first drug administration (washout period), the procedure was repeated using the alternate drug. The pharmacokinetic parameters, including AUCt, AUCinf, Cmax, t max, and t1/2, were determined based on the concentrations of the perindopril parent compound and the metabolite perindoprilat, using high-performance liquid chromatography method with tandem mass spectrometry detector (LC-MS/MS).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: Healthy male and female subjects Aged 18-55 years inclusive A body mass index in the range of 18-25 kg/m2 Able to participate, communicate well with the investigators and willing to give informed consent Non-smokers Vital signs (after 10 minutes resting) are within the following ranges: systolic blood pressure 100-125 mmHg diastolic blood pressure 60-80 mmHg pulse rate 60-90 bpm Exclusion Criteria: Pregnant or lactating women Known hypersensitivity or contraindication to perindopril Intake of any prescription drug within 14 days of this study's first dosing day Intake of any non-prescription drug, food supplement, or herbal medicine within 7 days of this study's first dosing day History or presence of any liver dysfunction (ALT, alkaline phosphatase, total bilirubin ≥ 1.5 ULN) History of any bleeding or coagulation disorders Clinically significant ECG abnormalities Clinically significant haematology abnormalities Renal insufficiency (plasma creatinine concentration ≥ 1.4 mg/dL) Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drug A donation or loss of 500 mL (or more) of blood within 3 months before this study's first dosing day A positive hepatitis B surface antigen (HBsAg), anti-HCV, and anti-HIV History of drug or alcohol abuse within 12 months prior to screening of this study Participation in a previous study within 3 months of this study's first dosing day
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location