Pharmacokinetics study of a single bolus intravenous injection of diclofenac sodium solution administered in male and female healthy volunteers

Phase 1

Completed

• Conditions: Not Applicable; Exposure (AUC) of diclofenac sodium in healthy adults

• Registration Number: ISRCTN20012465
• Lead Sponsor: IBSA Biochemical Institute (Institut Biochimique) S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-15
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. Informed consent
2. Females and males, 18-55 years old inclusive
3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm
5. Females of child-bearing potential using reliable methods of contraception
6. Females of non-child-bearing potential or in post-menopausal status for at least 1 year
7. For all female subjects, pregnancy test result must be negative at screening

Exclusion Criteria

1. ECG 12-leads (supine position): clinically relevant abnormalities
2. Clinically relevant abnormal physical findings
3. Clinically relevant abnormal laboratory values
4. Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients or other non-steroidal anti-inflammatory drugs (NSAIDs); history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study. History of asthma
5. Relevant history of significant renal, hepatic, gastrointestinal (in particular active or suspected gastrointestinal ulcers or bleeding), genitourinary, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study. History of haemorrhagic diathesis, thalassemia, sickle-cell disease, G6PD deficiency and any other condition that could potentially lead to haemolysis
6. Intake of medications, including over-the-counter (OTC) medications and herbal products for 2 weeks before the start of the study. In particular NSAID or anticoagulant use for 2 weeks before and during the entire study. Hormonal contraceptives for females are allowed
7. Participation in the evaluation of any investigational product in the 3 months before this study
8. Blood donations in the 3 months before this study
9. History of drug, alcohol [> 1 drink/day for females and >2 drinks/day for males, defined according to USDA Dietary Guidelines 2010 (8)], caffeine (>5 cups coffee/tea/day) or tobacco abuse (=10 cigarettes/day)
10. Positive result at the drug test at screening
11. Positive alcohol breath test
12. Abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
13. Positive or missing pregnancy test at screening or day -1, pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified