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

An open-label, randomized, four-period, crossover study to assess the effect of SMC021 (0.8 mg recombinant salmon calcitonin/200 mg 5-CNAC) on the pharmacokinetics of ibuprofen 600 mg and paracetamol 1G and the effects of ibuprofen and paracetamol on the pharmacokinetics of SMC021 in healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/001052

Enrollment

Registered

2010-01-20

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: SMC021: (0.8 mg recombinant salmon calcitonin/200 mg 5-CNAC) tablet, Intervention2: Ibuprofen: (600 mg) tablet, Intervention3: Paracetamol: (1G) tablet, Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male and female subjects age 35 to 65 years of age included, and in good health

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To assess the pharmacokinetic (PK) profiles of SMC021 and ibuprofen when administered alone compared to those when they are co-administered. To assess the pharmacokinetic (PK) profiles of SMC021 and paracetamol when administered alone compared to those when they are co-administered.Timepoint: Pharmacokinetic samples will be collected post dose up to 4 hours for SMC021, 6 hours for ibuprofen and 24 hours for paracetamol (day after dosing).	—

Measure

Time frame

To assess the pharmacokinetic (PK) profiles of SMC021 and ibuprofen when administered alone compared to those when they are co-administered. To assess the pharmacokinetic (PK) profiles of SMC021 and paracetamol when administered alone compared to those when they are co-administered.Timepoint: Pharmacokinetic samples will be collected post dose up to 4 hours for SMC021, 6 hours for ibuprofen and 24 hours for paracetamol (day after dosing).

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Secondary

Measure	Time frame
To evaluate the safety and tolerability of co-administration of SMC021 and ibuprofen, SMC021 and paracetamolTimepoint: Number Of AEs From First Dosing To End Of Study Evaluation And Number Of SAEs From Date Of ICF To 4weeks After Last Dose Administration	—

Countries

India

Contacts

Public ContactDr. K V Sureshkumar

Novartis Healthcare Pvt Ltd

suresh_kumar.kamireddy@novartis.com04067674611

Outcome results