Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01506076
Other study ID # 07446/07-08
Secondary ID
Status Completed
Phase Phase 1
First received January 5, 2012
Last updated January 6, 2012
Start date December 2007
Est. completion date January 2008

Study information

Verified date January 2012
Source Dr. Reddy's Laboratories Limited
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

A pivotal study to compare the Bioequivalence of Levocetirizine DiHCl Tablets 5 mg of Dr.Reddy's Laboratories Limited with XYZAL® Tablets 5 mg of UCB Farchim S.A. in healthy, human subjects under fasting conditions.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- Female volunteers who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.

- Female volunteers demonstrating a positive pregnancy screen.

- All female subjects will be screened for pregnancy at screening, check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.

- Female volunteers who are currently breast feeding. Female subjects who are pregnant, breast-feeding or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate.

- Subjects with positive urine screen for drugs of abuse at the time of admission check-in for each period will be excluded from the study.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Levocetirizine DiHCl
Levocetirizine DiHCl Tablets 5 mg

Locations

Country Name City State
India Vimta Labs Ltd., Hyderabad A.P

Sponsors (1)

Lead Sponsor Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bioequivalence is based on Cmax and AUC parameters 2 month No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03754920 - Prolonged Fasting With Meditation and Mild Physical Exercise N/A
Completed NCT05272332 - Gastric Ultrasound Prior to Extubation
Completed NCT04247464 - Short-term Fasting as an Enhancer of Chemotherapy: Pilot Clinical Study on Colorectal Carcinoma Patients N/A
Completed NCT01067001 - Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study N/A
Completed NCT00757094 - Safety and Feasibility of Fasting While Receiving Chemotherapy N/A
Completed NCT01506713 - Bioequivalence Study of Clopidogrel Tablets 75 mg of Dr. Reddy's Under Fasting Conditions Phase 1
Completed NCT04514380 - Effect of Drinking Carbohydrate-containing Fluids on Gastric Residual Volume in Elderly Patients
Completed NCT05756868 - The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior N/A
Completed NCT05134207 - The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty N/A
Completed NCT05031598 - Long-term Fasting: Multi-system Adaptations in Humans N/A
Recruiting NCT04501393 - Recommended Clear Fluid Intake Volume at 2 Hours Prior to Esophagogastroduodenoscopy for Adult Patients N/A
Enrolling by invitation NCT04027478 - Can Fasting Decrease the Side Effects of Chemotherapy? N/A
Completed NCT05219136 - Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol N/A
Recruiting NCT04625608 - Effect of Premedicant Oral Paracetamol on Gastric Volume and pH Phase 4
Not yet recruiting NCT02562638 - Pre-Procedural Fasting in Cardiac Intervention N/A
Completed NCT01949987 - Does Oral Intake Decreases Postoperative Pain Score in Children N/A
Completed NCT01954836 - Short-Term Fasting During Chemotherapy in Patients With Gynecological Cancer- a Randomized Controlled Cross-over Trial N/A
Completed NCT01831700 - Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions Phase 1
Completed NCT01721187 - Satiety Effects on the Neural Valuation of Food N/A
Completed NCT01713647 - Bioequivalence Study of Amlodipine / Losartan/ Hydrochlorothiazide of PHARMALINE, Lebanon Under Fastion Conditions Phase 1