A clinical trial to study the effect of SMC021 on the blood levels of ibuprofen and paracetamol and the effect of ibuprofen and paracetamol in blood levels of SMC021
Phase 1
- Registration Number
- CTRI/2009/091/001052
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 56
Inclusion Criteria
Healthy male and female subjects age 35 to 65 years of age included, and in good health
Exclusion Criteria
Significant illness within 2 weeks prior to dosing, history of ECG abnormalities, chronic illness associated with changes in bone density, recent or recurrent history of acute or chronic bronchospastic disease, autonomic dysfunction, cancer, medical or sugical condition whicch might alter the ADME of drug, positive hep and HIV screen, and bleeding disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the pharmacokinetic (PK) profiles of SMC021 and ibuprofen when administered alone compared to those when they are co-administered.<br><br>To assess the pharmacokinetic (PK) profiles of SMC021 and paracetamol when<br>administered alone compared to those when they are co-administered.Timepoint: Pharmacokinetic samples will be collected post<br>dose up to 4 hours for SMC021, 6 hours for ibuprofen and 24 hours for paracetamol (day after dosing).
- Secondary Outcome Measures
Name Time Method To evaluate the safety and tolerability of co-administration of SMC021 and ibuprofen, SMC021<br>and paracetamolTimepoint: Number Of AEs From First Dosing To<br>End Of Study Evaluation And Number Of<br>SAEs From Date Of ICF To 4weeks After<br>Last Dose Administration