Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fed Condition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IPCA Laboratories Ltd.
ClinicalTrials.gov Identifier:
NCT01567501
First received: March 23, 2012
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

This is a single-dose, Randomized, two-period,cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in normal, healthy, adult, human subjects.


Condition Intervention Phase
Fed
Drug: Levocetirizine Dihydrochloride tablets 5 mg
Drug: Levocetirizine Dihydrochloride
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, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Levocetirizine Dihydrochloride 5 mg Tablets With Xyzal® 5 mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fed Condition

Resource links provided by NLM:


Further study details as provided by IPCA Laboratories Ltd.:

Primary Outcome Measures:
  • Bioequivalence is based on Cmax and AUC parameters. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Sampling Hours: Pre-dose and at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 12.00, 24.00, 36.00 and 48.00 hours post-dose.


Enrollment: 28
Study Start Date: February 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levocetirizine Dihydrochloride tablets 5 mg
Levocetirizine dihydrochloride Tablets, 5 mg of M/s Ipca Laboratories Limited, India
Drug: Levocetirizine Dihydrochloride tablets 5 mg
5 mg tablet once in a day
Other Name: Test product
Active Comparator: Xyzal
XYZAL (levocetirizine dihydrochloride) 5 mg Tablets of M/s UCB Inc.,USA
Drug: Levocetirizine Dihydrochloride
5 mg tablet once in a day
Other Name: Xyzal

Detailed Description:

Primary Objective of this pivotal study was to assess the bioequivalence between Test Product: Levocetirizine Dihydrochloride 5 mg Tablets of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Xyzal® (levocetirizine dihydrochloride) 5 mg Tablets of M/s UCB Inc.,USA, under fed condition in normal, healthy, adult, human subjects in a randomized crossover study.

Secondary Objective was to monitor the safety and tolerability of a single oral dose of Levocetirizine Dihydrochloride 5 mg Tablets in normal,healthy, adult, human subjects.

The study was conducted with 28 healthy adult subjects. In each study period, a single 5 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 11 days including washout period of at least 7 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:

  • Male and non-pregnant female human subjects, age in the range of 18 - 45 years (both inclusive).
  • 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 signs (blood pressure, pulse rate, respiration rate and oral temperature).
  • Subjects with clinically acceptable findings as determined by haemogram, biochemistry, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if required).
  • Willingness to follow the protocol requirements as evidenced by written informed consent.
  • Confirming and agreeing to, not using any prescription and over the counter medications including vitamins and minerals for 14 days prior to study and during the course of the study.
  • No history of drug abuse in the past one year.
  • Non-smokers and non-alcoholics.
  • For female subject is 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
  • Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).

Exclusion Criteria:

  • Known history of hypersensitivity to Levocetirizine or to Cetirizine, or related drugs.
  • Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
  • 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, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.
  • Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.
  • History of malignancy or other serious diseases.
  • Refusal to abstain from food for at least ten (10.00) hours prior to receiving the high-fat and high-calorie breakfast and for at least four (04.00) hours post-dose, in each study period.
  • Any contraindication to blood sampling or difficulty in accessibility of veins.
  • Refusal to abstain from fluid for at least 01.00 hour prior to study drug administration and for at least 01.00 additional hour post-dose, in each study period except about 240 mL of water given during administration of study drug.
  • 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.
  • Blood donation within 90 days prior to the commencement of the study.
  • Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.
  • Found positive in breath alcohol test done before check-in for each study period.
  • Found positive in urine test for drugs of abuse done before check-in for each study period.
  • Refusal to abstain from consumption of tobacco products 24.00 hours prior to dosing until the last blood sample collection of last study period.
  • History of problem in swallowing Tablet(s).
  • Female subject, demonstrating positive urine pregnancy test at the time of screening.
  • Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period.
  • Female subject, currently breast feeding or lactating.
  • Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567501

Locations
India
Accutest Research Lab (I) Pvt. Ltd.
Ahmedabad, Gujarat, India, 380054
Sponsors and Collaborators
IPCA Laboratories Ltd.
Investigators
Principal Investigator: Dr. Rupesh Vala, M.B.B.S. Accutest Research Lab (I) Pvt. Ltd.
  More Information

No publications provided

Responsible Party: IPCA Laboratories Ltd.
ClinicalTrials.gov Identifier: NCT01567501     History of Changes
Other Study ID Numbers: Ipca/ARL/059
Study First Received: March 23, 2012
Last Updated: November 30, 2012
Health Authority: India: Ministry of Health
United States: Institutional Review Board

Additional relevant MeSH terms:
Levocetirizine
Cetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014