Bioequivalence Study of Two Formulations of 10 mg Lisinopril Tablet Under Fasting Condition

NCT01936012 | Completed

• 1 other identifier: BE.258/EQL/2012
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The present study was conducted to find out whether the bioavailability of 10 mg lisinopril tablets produced by PT Dexa Medica was equivalent to the tablets produced by the innovator (Zestril® 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, under license from Astra Zeneca UK Ltd.)

Conditions

Healthy

Keywords

Lisinopril; Bioequivalence; Bioavailability; Pharmacokinetic; Angiotensin-converting enzyme inhibitor

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration-time curve from time zero to the last observed quantifiable concentration (AUCt) of lisinopril

  Relative bioavailability (primarily measured by AUCt and AUCinf) between two lisinopril 10 mg tablet formulations (test and reference formulations) was assessed under fasting condition. AUCt was determined from plasma concentration of lisinopril.

  48 hours

• Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of lisinopril

  Relative bioavailability (primarily measured by AUCt and AUCinf) between two lisinopril 10 mg tablet formulations (test and reference formulations) was assessed under fasting condition. AUCinf was determined from plasma concentration of lisinopril.

  48 hours

Secondary Outcomes (3)

• The peak plasma concentration (Cmax) of lisinopril

  48 hours

• Time needed to achieve the peak plasma concentration (t max) of lisinopril

  48 hours

• The elimination half-life (t1/2) of lisinopril

  48 hours

Study Arms (2)

Lisinopril 10 mg tablets of PT Dexa Medica

EXPERIMENTAL

Each tablet contains 10.89 mg lisinopril dihydrate that equal to 10 mg lisinopril. A single dose of lisinopril tablet of PT Dexa Medica was given to each of study subjects.

Drug: Lisinopril 10 mg tablets of PT Dexa Medica

Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia

ACTIVE COMPARATOR

Each tablet contains 10.89 mg lisinopril dihydrate that equal to 10 mg lisinopril. A single dose of lisinopril tablet of PT Boehringer Ingelheim Indonesia was given to each of study subjects.

Drug: Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia

Interventions

Lisinopril 10 mg tablets of PT Dexa Medica DRUG

Each tablet contains 10.89 mg of lisinopril dihydrate that equal to 10 mg lisinopril. Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.

Also known as: Test Product: Lisinopril 10 mg tablets of PT Dexa Medica

Lisinopril 10 mg tablets of PT Dexa Medica

Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia DRUG

Each tablet contains 10.89 mg of lisinopril dihydrate that equal to 10 mg lisinopril. Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.

Also known as: Reference product: Zestril® 10 mg, produced by PT Boehringer Ingelheim Indonesia, under license from Astra Zeneca UK Ltd..

Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects.
• Aged 18 - 55 years inclusive.
• Non-smokers or moderate smokers (less than 10 cigarettes per day).
• Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
• Body mass index within 18 to 25 kg/m2.
• Vital signs (after 10 minutes rest) were within the following ranges:
• systolic blood pressure 110 - 120 mmHg
• diastolic blood pressure 70 - 80 mmHg
• pulse rate 60 - 90 bpm

You may not qualify if:

• Personal/family history of allergy or hypersensitivity or contraindication to lisinopril or allied drugs.
• Pregnant or lactating women.
• Any major illness or clinically significant ongoing chronic medical illness in the past 90 days.
• Any clinically significant abnormality of liver function test (ALT, AP, total bilirubin \>= 1.5 ULN).
• Any clinically significant abnormality of renal function test (serum creatinine concentration \> 1.4 mg/dL).
• Positive hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
• Clinically significant hematology abnormalities.
• Clinically significant electrocardiogram (ECG) abnormalities.
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drug.
• Past history of anaphylaxis or angioedema.
• History of drug or alcohol abuse within 12 months prior to screening.
• Participation in any clinical trial within the past 90 days.
• History of any bleeding or coagulative disorders.
• History of difficulty with donating blood or accessibility of veins in left or right arm.
• A donation or loss of 500 mL (or more) of blood within 3 months before the study's first dosing day.

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (1)

PT Equilab International

Jakarta, Jakarta Special Capital Region, 12430, Indonesia

Location

MeSH Terms

Interventions

Lisinopril

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2013
• First Posted: September 5, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

ID (1)