Bioequivalence Study of Lisinopril Tablets 40 mg Under Fed Condition

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01735344
• Date of registration: 05/11/2012
• Prospective Registration: No
• Primary sponsor: IPCA Laboratories Ltd.
• Public title: Bioequivalence Study of Lisinopril Tablets 40 mg Under Fed Condition
• Scientific 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 Fed Conditions.
• Date of first enrolment: June 2012
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01735344
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

India

Contacts

• Name: Dr. Suhas Khandave, M.D.
• Affiliation: Accutest Research Lab (I) Pvt. Ltd.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Fed

Intervention(s)

Drug: Lisinopril Tablets 40 mg

Drug: Lisinopril

Primary Outcome(s)

Cmax [Time Frame: 2 months]

AUC [Time Frame: 2 months]

Secondary ID(s)

Ipca/ARL-10/385

Source(s) of Monetary Support

Please refer to primary and secondary sponsors