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NCT Number: NCT01682577

Bioequivalence Study of Two Formulations of Perindopril 4 mg Tablet Under Fasting Condition

The objective of this study was to find out whether the bioavailability of PT Dexa Medica's formulation of 4 mg perindopril tert-butylamine tablets was equivalent to that of the innovator's product (Prexum® 4 mg, Servier).

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PT Equilab International

Jakarta, Jakarta Special Capital Region, 12430, Indonesia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perindopril 4 mg tablets of PT Dexa Medica

Drug

Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.

Other names: Test Product: Perindopril 4 mg tablets of PT Dexa Medica., Each tablet contains perindopril tert-butylamine salt 4 mg

Perindopril 4 mg tablets of Servier

Drug

Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.

Other names: Reference product: Prexum® 4 mg, produced by Servier., Each tablet contains Perindopril tert-butylamine salt 4 mg.

Primary outcomes

  1. Area under concentration-time curve (AUC)of perindopril parent compound

    Time frame: 192 hours

    Relative bioavailability (primarily measured by AUCt and AUCinf) between two perindopril 4 mg tablet formulations (test and reference formulations) under fasting condition. The AUC was measured based on the plasma concentration of perindopril parent compound.

  2. Area under concentration-time curve (AUC)of perindoprilat

    Time frame: 192 hours

    Relative bioavailability (primarily measured by AUCt and AUCinf) between two perindopril 4 mg tablet formulations (test and reference formulations) under fasting condition. The AUC was measured based on the plasma concentration of the active metabolite, perindoprilat.

Secondary outcomes

  1. Peak plasma concentration (Cmax)of perindopril parent compound

    Time frame: 192 hours

    Relative bioavailability (secondarily measured by Cmax) between two perindopril 4 mg tablet formulations (test and reference formulations) under fasting condition. The Cmax was measured based on the plasma concentration of perindopril parent compound.

  2. Peak plasma concentration (Cmax)of perindoprilat

    Time frame: 192 hours

    Relative bioavailability (secondarily measured by Cmax) between two perindopril 4 mg tablet formulations (test and reference formulations) under fasting condition. The Cmax was measured based on the plasma concentration of the active metabolite, perindoprilat.

  3. Time to achieve the peak plasma concentration (tmax)of perindopril parent compound

    Time frame: 192 hours

  4. Time to achieve the peak plasma concentration (tmax)of perindoprilat

    Time frame: 192 hours

  5. Elimination half-life (t1/2)of perindopril parent compound

    Time frame: 192 hours

  6. Elimination half-life (t1/2)of perindoprilat

    Time frame: 192 hours

Sponsors and collaborators

Lead sponsor

Dexa Medica Group

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 11, 2012
Registry last updated
Sep 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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