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Comparison of plasma concentration of rasagiline in different doses with genetic variations and smoking in healthy volunteers

Rasagiline Pharmacokinetics in CYP1A2 variant healthy smokers and non-smokers in different doses

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN68198254
Enrollment
108
Registered
2016-05-18
Start date
2016-06-01
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Parkinson's disease Nervous System Diseases

Interventions

Healthy volunteers will be recruited and screening for blood, hepatic and renal functions will be performed to fulfill the inclusion criteria in this study. Genotyping will be carried out for variant

Sponsors

University of Health Sciences Lahore
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers of both sexes 2. Age between 18 to 30 years 3. Body Mass Index <30 (BMI=weight/height2) 4. Smoking will be defined as present if a participant reports to be smoking at the time of survey either daily or occasionally 5. Non-smoker is a person who does not smoke at all or at the time of survey

Exclusion criteria

Exclusion criteria: 1. Volunteers with unstable medical condition or deranged CBC, LFT & RFT 2. Volunteers with history of drug allergies 3. Volunteers who have received any medication which is substrate for CYP1A2 4. Volunteers who have donated blood within 2 months 5. Pregnant women

Design outcomes

Primary

MeasureTime frame
Dose of rasagiline required to ensure effective plasma concentrations to achieve clinical response in participants with CYP1A2 A/A, A/C & C/C variant and smokers measured using pharmacokinetic variables (Cmax, Tmax, AUC, t1/2,Vd & Cl), at (0, 0.25, 0.30, 1,2,4,6, 8, 10 & 14 & 18hrs)

Countries

Pakistan

Contacts

Public ContactRabiea Munir

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026