Relative bioavailability of diclofenac potassium different formulations in healthy subjects.

An open label, randomized, three period, six sequence, crossover study to determine the bioavailability of diclofenac potassium soft-gelatin capsule as compared to diclofenac potassium powder for oral solution and diclofenac potassium tablet in healthy subjects

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/11/003106

Enrollment

Registered

2012-11-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Diclofenac potassium soft-gelatin (50mg) capsule: Single oral dose once daily for one day Control Intervention1: Diclofenac 50 mg tablet: Single oral dose once daily for one day Control

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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

Exclusion criteria: 1. 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
To assess the safety of diclofenac potassium formulations used in this study in healthy subjects.Timepoint: Monitoring of AE throughout the study	—

Countries

India

Contacts

Public ContactPrafulla Bhad

Novartis Healthcare Pvt. Ltd.

prafulla.bhad@novartis.com04067673287

Outcome results