Bioequivalence Study of Lisinopril Tablets 40 mg Under Fasting Condition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IPCA Laboratories Ltd.
ClinicalTrials.gov Identifier:
NCT01735318
First received: November 5, 2012
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, male and female human subjects.


Condition Intervention Phase
Fasting
Drug: Lisinopril Tablets 40 mg
Drug: Lisinopril
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Balanced, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Lisinopril Tablets 40 mg With Zestril® (Lisinopril) 40 mg Tablets in Normal, Healthy, Adult, Male and Female Human Subjects Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by IPCA Laboratories Ltd.:

Primary Outcome Measures:
  • Cmax [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Sampling Hours: Pre-dose and at 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 6.25, 6.50, 6.75, 7.00, 7.25, 7.50, 7.75, 8.00, 8.50, 9.00, 10.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hours post dose

  • AUC [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Sampling Hours: Pre-dose and at 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 6.25, 6.50, 6.75, 7.00, 7.25, 7.50, 7.75, 8.00, 8.50, 9.00, 10.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hours post dose


Enrollment: 40
Study Start Date: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lisinopril Tablets 40 mg
Lisinopril Tablets 40 mg of Ipca Laboratories Limited, India
Drug: Lisinopril Tablets 40 mg
40 mg tablet once a day
Other Name: Test Product
Active Comparator: Zestril® (Lisinopril) 40 mg Tablets
Zestril® (Lisinopril) 40 mg Tablets of AstraZeneca Pharmaceuticals LP USA
Drug: Lisinopril
40 mg tablet once a day
Other Name: Zestril® (Lisinopril) 40 mg Tablets

Detailed Description:

Objective of this pivotal study was to assess the bioequivalence between Test Product: Lisinopril Tablets 40 mg of Ipca Laboratories Limited, India and the corresponding Reference Product: Zestril® (Lisinopril) 40 mg Tablets of AstraZeneca Pharmaceuticals LP USA, under fasting condition in normal, healthy, adult, male and female human subjects in a randomized crossover study.

The study was conducted with 40 healthy adult subjects. In each study period, a single 40 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.

The duration of the clinical phase was approximately 19 days including washout period of 15 days between administrations of study drug in each study period.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and non pregnant female human subjects, age in the range of 18 - 45 years.
  2. Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
  3. Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and axillary temperature).
  4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urinalysis and 12 lead ECG.
  5. Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and tobacco products for 48 hours prior to dosing until after the last blood sample collection in each study period and adherence to food, fluid and posture restrictions.
  6. No history of significant alcoholism.
  7. No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 6 months.
  8. Non-smokers were included.

Exclusion Criteria:

  1. Known history of hypersensitivity to Lisinopril or related drugs.
  2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
  3. Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of Investigational Product.
  4. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
  5. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
  6. Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
  7. History of malignancy or other serious diseases.
  8. Blood donation 90 days prior to the commencement of the study.
  9. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
  10. Found positive in breath alcohol test.
  11. Found positive in urine test for drug abuse.
  12. History of problem in swallowing.
  13. Any contraindication to blood sampling.
  14. Found positive serum Beta- hCG (Human Chorionic Gonadotropin) test.
  15. Lactating women (currently breast feeding).
  16. Female subjects not confirming to using birth control measures, from the date of screening until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) were acceptable. Use of hormonal contraceptives either oral or implants.
  17. Female subjects whose menstruation cycle coincided with the study periods.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735318

Locations
India
Accutest Research Lab (I) Pvt. Ltd.
Navi-Mumbai, Maharashtra, India
Sponsors and Collaborators
IPCA Laboratories Ltd.
Investigators
Principal Investigator: Dr. Suhas Khandave, M.D. Accutest Research Lab (I) Pvt. Ltd.
  More Information

No publications provided

Responsible Party: IPCA Laboratories Ltd.
ClinicalTrials.gov Identifier: NCT01735318     History of Changes
Other Study ID Numbers: Ipca/ARL-10/384
Study First Received: November 5, 2012
Last Updated: November 30, 2012
Health Authority: India: Ministry of Health
United States: Institutional Review Board

Additional relevant MeSH terms:
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014