Relative bioavailability of diclofenac potassium different formulations in healthy subjects.

Phase 1/2

Completed

• Conditions: Healthy adults

• Registration Number: CTRI/2012/11/003106
• Lead Sponsor: Novartis Healthcare Private Limited

Brief Summary

This is an open-label, randomized, crossover study in healthy subjects. The study will consists of 28-days screening period , three baseline period(s) (one before each treatment period), three treatment periods, washout period of of 3-7 days from the last dosing followed by end of study evaluation approximately 24 hours after last drug administration.

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|Initial Baseline: Subjects who meet the eligibility criteria at screening will be admitted to baseline evaluations. All baseline safety evaluation results must be available prior to dosing.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

 Treatment Period:  The administration of the diclofenac formulations will take place in fasting conditions in all the three periods with 240 mL of water as per the randomization list. Following administration of the appropriate diclofenac formulation, blood samples will be collected at specified timepoints up to 12 hours post dose to estimate diclofenac concentrations. Subjects will be domiciled for approximately 36 hours (Day -1 to Day 2). Subjects will be discharged from the clinical site after completing the assessments scheduled on Day 2 in each period. Subjects will come back to the site for treatment Period 2 and 3 after a washout of at least 3 days from the last dose. They will receive the treatment that is different from the one

received in period 1, and they will repeat all procedures they underwent in period 1 in period 2 and 3.

 For all treatment groups, standard lunch, snacks and dinner will be served at approximately 4, 8 and 12 hours post dose.

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In addition to the routine safety assessments performed at specified time points during the study, the subjects will also be monitored for adverse events throughout the study. Any AE occurring during this time will be evaluated by the investigator as to whether it is related to the study drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-15
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Healthy male and female subjects 2.
• Subjects must weigh atleast 50 kg and their BMI should be within range of 18-30 kg/m2 3.
• Women of child-bearing potential must use effective contraception during the study.

Exclusion Criteria

• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes 2.
• Pregnant or nursing (lactating) women 3.
• History of clinically significant ECG abnormalities, malignancy of any organ system, history of immunodeficiency diseases; of drug or alcohol abuse.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare bioavailability of 50 mg diclofenac potassium formulations in healthy subjects under fasting conditions.	Based on blood samples collected at multiple time points over 12 hours post dose.

Secondary Outcome Measures

Name	Time	Method
To assess the safety of diclofenac potassium formulations used in this study in healthy subjects.	Monitoring of AE throughout the study

Trial Locations

Locations (1)

Lotus Labs Pvt. Ltd.; 🇮🇳 Bangalore, KARNATAKA, India

Lotus Labs Pvt. Ltd.

🇮🇳Bangalore, KARNATAKA, India

Dr Anil Kumar Anand

Principal investigator

918028567270

anil_ka@lotuslabs.com