NCT01506076

Brief Summary

The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets 5mg with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance, under fasting conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2012

Completed
Last Updated

January 9, 2012

Status Verified

January 1, 2012

Enrollment Period

1 month

First QC Date

January 5, 2012

Last Update Submit

January 6, 2012

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence is based on Cmax and AUC parameters

    2 month

Study Arms (2)

Levocetirizine DiHCl Tablets, 5 mg

EXPERIMENTAL

Levocetirizine DiHCl Tablets, 5 mg of Dr. Reddy's Laboratories Ltd.

Drug: Levocetirizine DiHCl

XYZAL

ACTIVE COMPARATOR

XYZAL Tablets 5 mg of UCB Farchim S.A.

Drug: Levocetirizine DiHCl

Interventions

Levocetirizine DiHClDRUG

Levocetirizine DiHCl Tablets 5 mg

Also known as: XYZAL
Levocetirizine DiHCl Tablets, 5 mgXYZAL

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects will provide written informed consent.
  • Subjects must be healthy adults within 18-45 years of age (inclusive).
  • Body mass index of ≥18.5 kg/m2 and ≤25 kg/m2, with body weight not less than 50 kg.
  • Subjects must be of normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the dosing in Period-I.
  • Have normal ECG, chest X-Ray and vital signs and clinically non significant changes in ECG \& chest X-Ray.
  • Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
  • Subjects will be Non smokers or moderate smokers (less than 10 cigarettes a day) for at least 6 months.
  • If subject is a female volunteer and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device(IUD), or abstinence.
  • or is postmenopausal for at least 1 year. is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
  • Each female subject will be given a urine pregnancy test at screening, check-in for period-1, period-2 and post study.

You may not qualify if:

  • Subjects incapable of understanding the informed consent.
  • Subjects with BP lesser than 90/60 mm of Hg or BP greater than or equal to 140/90 mm of Hg.
  • History of hypersensitivity or idiosyncratic reaction to Levocetirizine or other related drugs.
  • Any evidence of impairment of renal, hepatic, gastro intestinal, lung and cardiac function.
  • Subjects with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for the study.
  • Regular smoker who smokes more than ten cigarettes daily or has difficulty in abstaining from smoking for the duration of each study period.
  • Subjects who have taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within the past two weeks prior to prior to dosing in Period-1.
  • History of any psychiatric illness, which may impair the ability to provide written, informed consent.
  • Subject is mentally or legally incapacitated, or has a history of significant psychiatric disorder.
  • Subjects who have a history of alcohol or substance/ drug of abuse within the last 5 years.
  • Subjects with clinically significant abnormal values of laboratory parameters, including positive results of HIV, HBV, HCV, RPR tests.
  • Subjects who participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
  • Subjects who are unable to or likely to be non-compliant with protocol requirements or restrictions.
  • Subjects who are intolerant to venipuncture.
  • Any subject in whom Levocetirizine Dihydrochloride is contraindicated for medical reasons.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vimta Labs Ltd.,

Hyderabad, A.P, 500 051, India

Location

MeSH Terms

Conditions

Fasting

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Sudershan Vishwanath, MD

    Vimta Labs 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

January 5, 2012

First Posted

January 9, 2012

Study Start

December 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 9, 2012

Record last verified: 2012-01

Locations

IN(1)