Bioequivalence Study of Lisinopril Tablets 40 mg Under Fasting Condition

NCT01735318 | Completed Phase 1 DMC

• 1 other identifier: Ipca/ARL-10/384
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fasting

Outcome Measures

Primary Outcomes (2)

• Cmax

  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

  2 months

• AUC

  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

  2 months

Study Arms (2)

Lisinopril Tablets 40 mg

EXPERIMENTAL

Lisinopril Tablets 40 mg of Ipca Laboratories Limited, India

Drug: Lisinopril Tablets 40 mg

Zestril® (Lisinopril) 40 mg Tablets

ACTIVE COMPARATOR

Zestril® (Lisinopril) 40 mg Tablets of AstraZeneca Pharmaceuticals LP USA

Drug: Lisinopril

Interventions

Lisinopril Tablets 40 mg DRUG

40 mg tablet once a day

Also known as: Test Product

Lisinopril Tablets 40 mg

Lisinopril DRUG

40 mg tablet once a day

Also known as: Zestril® (Lisinopril) 40 mg Tablets

Zestril® (Lisinopril) 40 mg Tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and non pregnant female human subjects, age in the range of 18 - 45 years.
• Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
• Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and axillary temperature).
• Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urinalysis and 12 lead ECG.
• 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.
• No history of significant alcoholism.
• No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 6 months.
• Non-smokers were included.

You may not qualify if:

• Known history of hypersensitivity to Lisinopril or related drugs.
• Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
• Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of Investigational Product.
• Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
• History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
• Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
• History of malignancy or other serious diseases.
• Blood donation 90 days prior to the commencement of the study.
• Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
• Found positive in breath alcohol test.
• Found positive in urine test for drug abuse.
• History of problem in swallowing.
• Any contraindication to blood sampling.
• Found positive serum Beta- hCG (Human Chorionic Gonadotropin) test.
• Lactating women (currently breast feeding).

Sponsors & Collaborators

• IPCA Laboratories Ltd.: lead

Study Sites (1)

Accutest Research Lab (I) Pvt. Ltd.

Navi Mumbai, Maharashtra, India

Location

MeSH Terms

Conditions

Fasting

Interventions

Lisinopril

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dr. Suhas Khandave, M.D.

  Accutest Research Lab (I) Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 28, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

IN (1)