Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fed Condition
|Fed||Drug: Levocetirizine Dihydrochloride tablets 5 mg Drug: Levocetirizine Dihydrochloride||Phase 1|
|Study Design:||Allocation: Randomized
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|
- Bioequivalence is based on Cmax and AUC parameters. [ Time Frame: 1 month ]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.
|Study Start Date:||February 2012|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567501
|Accutest Research Lab (I) Pvt. Ltd.|
|Ahmedabad, Gujarat, India, 380054|
|Principal Investigator:||Dr. Rupesh Vala, M.B.B.S.||Accutest Research Lab (I) Pvt. Ltd.|