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Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT01831700
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : April 15, 2013
Sponsor:
Information provided by (Responsible Party):
IPCA Laboratories Ltd.

Brief Summary:
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over 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, human subjects.

Condition or disease Intervention/treatment Phase
Fasting Drug: Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Drug: Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets Phase 1

Detailed Description:

Objective of this pivotal study was to assess the bioequivalence between Test Product: Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of M/s Ipca Laboratories Ltd., India and the corresponding Reference Product: Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets of M/s AstraZeneca Pharmaceuticals LP, USA under fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.

The study was conducted with 48 healthy adult subjects. In each study period, a single Lisinopril and Hydrochlorothiazide Tablets (20+25) mg 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 clinical phase was 12 days, including the washout period of 7 days between each study period.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Comparative Bioavailability Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of M/s Ipca Laboratories Ltd., India With Zestoretic® 20/25 Lisinopril/Hydrochlorothiazide Tablets of M/s AstraZeneca Pharmaceuticals LP, USA in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
Study Start Date : October 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lisinopril and Hydrochlorothiazide Tablets (20+25) mg
Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of M/s Ipca Laboratories Ltd., India
Drug: Lisinopril and Hydrochlorothiazide Tablets (20+25) mg
Lisinopril and Hydrochlorothiazide (20+25) mg Tablets once a day
Other Name: Test product

Drug: Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets
Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets once a day
Other Name: Reference product

Active Comparator: Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets
Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets of M/s AstraZeneca Pharmaceuticals LP, USA
Drug: Lisinopril and Hydrochlorothiazide Tablets (20+25) mg
Lisinopril and Hydrochlorothiazide (20+25) mg Tablets once a day
Other Name: Test product

Drug: Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets
Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets once a day
Other Name: Reference product




Primary Outcome Measures :
  1. Bioequivalence is based on Cmax and AUC parameters. [ Time Frame: 1 Months ]
    Sampling Hours: Pre-dose and at 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and non-pregnant female human subjects, age in the range of 18 - 45 years (both inclusive).
  2. Subject willing to give written informed consent.
  3. Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
  4. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).
  5. Subjects with clinically acceptable findings as determined by haemogram, biochemistry including serum electrolytes test, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if taken).
  6. Willingness to follow the protocol requirements as evidenced by written informed consent.
  7. Confirming and agreeing to, not using any prescription and over the counter medications including vitamins and minerals for 14 days prior to study & during the course of the study.
  8. No history of drug abuse in the past one year.
  9. Non-smokers and Non-alcoholics.
  10. For female subject:

    • Was child bearing potential practicing acceptable method of birth control for the duration of the study as judged by Investigator such as Condom, Foams, Jellies, Diaphragm , Intrauterine device and Abstinence. OR
    • Was surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).

Exclusion Criteria:

  1. Known history of hypersensitivity to Lisinopril and Hydrochlorothiazide, other sulfonamide-derived drugs or related drugs.
  2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
  3. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
  4. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.
  5. Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.
  6. History of malignancy or other serious diseases.
  7. Refusal to abstain from food from at least ten (10.00) hours prior to study drug administration until at least four (04.00) hours post-dose, in each study period.
  8. Any contraindication to blood sampling or difficulty in accessibility of veins.
  9. Refusal to abstain from fluid from at least 01.00 hour prior to study drug administration until at least 01.00 hour post-dose, in each study period except about 240 mL of water given during administration of study drug.
  10. Refusal to avoid the use of xanthine-containing food or beverages (chocolates, tea, coffee or cola drinks) or fruit juice/grapefruit juice and any alcoholic products for 48.00 hours prior to dosing until the last blood sample collection of last study period.
  11. Blood donation within 90 days prior to the commencement of the study.
  12. Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.
  13. Found positive in breath alcohol test done before check-in for each study period.
  14. Found positive in urine test for drug abuse done before check-in for each study period.
  15. Refusal to abstain from consumption of tobacco products 24.00 hours prior to dosing until the last blood sample collection of last study period.
  16. History of problem in swallowing tablet(s).
  17. Female subject, demonstrating positive urine pregnancy test at the time of screening.
  18. Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period.
  19. Female subject, currently breast feeding or lactating.
  20. Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831700


Locations
India
Accutest Research Lab (I) Pvt. Ltd.
Ahmedabad, Gujarat, India, 380059
Sponsors and Collaborators
IPCA Laboratories Ltd.
Investigators
Principal Investigator: Dr. Tarang Girishbhai Shah, M. D. (Pharmacology) Accutest Research Lab (I) Pvt. Ltd.

Responsible Party: IPCA Laboratories Ltd.
ClinicalTrials.gov Identifier: NCT01831700     History of Changes
Other Study ID Numbers: Ipca/ARL/10/386
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Hydrochlorothiazide, lisinopril drug combination
Hydrochlorothiazide
Lisinopril
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents