A Clinical trial study to evaluate the blood concentration and safety of single and multiple Diclofenac Sodium topical patches following single-day and multiple-day applicatio

Phase 1

Completed

• Registration Number: CTRI/2009/091/000492
• Lead Sponsor: Cerimon Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Healthy male or female volunteers aged 18 - 75 years

2. Provide written informed consent to

participate in all aspects of the study

3. Have a negative urine pregnancy test result, prior to study entry, for all female subjects of childbearing potential

4. Use an effective birth control method and a willingness to continue birth control during the study and for 2 weeks following the study, for female subjects of childbearing potential

Exclusion Criteria

1. A history of intolerance or hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
2. A history of hypersensitivity to Diclofenac or Diclofenac-containing products
3. A history of asthma within 1 year of study entry
4. A history of peptic ulcer within 1 year of study entry, any history of gastrointestinal bleeding or coagulation disorder (with the exception of bleeding due to internal or external hemorrhoids)
5. Current smoker or history of smoking within 6 months of study entry
6. Clinically significant active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular disease
7. Clinically significant abnormal clinical laboratory test results during screening period
8. Positive test result for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV)
9. Allergy to adhesives (e.g. adhesive tape)
10. Topical lotions, creams or gels applied to the application site within 7 days prior to randomization
11. Active skin disease involving the back (general area where patch(es) will be applied)
12. Excessive hair, abrasion, irritation, bruising, scarring or other damage to the skin of the back area
13. Any medications including prescription, over-the-counter and herbal products within 30 days prior to dosing. If any medication has been used infrequently during this window, the sponsor will be contacted to determine eligibility.
14. Positive urine drug screen for any drug of abuse (including but not limited to amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines)
15. Positive alcohol breath test. Subjects will be instructed to refrain from alcohol use for at least 48 hours prior to screening, and during confinement/dosing period and follow-up period.
16. Treatment with an investigational drug or device within 30 days before study entry
17. Treatment with an investigational biologic within 6 months before study entry
18. Blood donation within 30 days of enrollment
19. Any ECG abnormalities unless approved by the Medical Monitor
20. Pregnant or breast-feeding females

Study & Design

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