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To study the distribution of nanoparticles of of rifampicin in healthy human volunteers

Bioevaluation of PLGA loaded with radio-labeled Rifampicin: A prospective study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040372
Enrollment
16
Registered
2022-02-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

None listed

Interventions

Intervention1: Rifampicin loaded PLGA nanoparticles: 450 mg oral signal dose Control Intervention1: Rifampicin: 450 mg oral single dose

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Normal healthy male volunteers. 2. Age 18 - 45 yrs. 3. Willing to give written, informed consent 4. Willing to comply with protocol requirements 5. Normal physical & systemic examination 6. Biochemistry & hematology (within 15% of laboratory range will be acceptable) 7. No abnormality detected on X-ray chest & ECG 8. No laboratory evidence of hepatic, renal or cardiac dysfunction

Exclusion criteria

Exclusion criteria: 1) History of having donated blood in the past 3 months. 2) HIV or HBs Ag positivity 3) History of any drug intake in the past 15 days 4) History of receiving any enzyme-inducing agent in the past 15 days 5) History of participating in any IND study in last 6 months 6) History of participating in any non-IND study in the past 3 months 7) History of allergy or hypersensitivity to any medication 8) History of peptic disorder 9) Chronic smoker >6 cigarettes/beedies per day 9) Chronic smoker >6 cigarettes/beedies per day 9) Chronic smoker >6 cigarettes/beedies per day 9) Chronic smoker >6 cigarettes/beedies per day 9) Chronic smoker >6 cigarettes/beedies per day 13) History of any chronic disease and taking medication 13) History of any chronic disease and taking medication 15) History of any major illness in past a. (viz. meningitis, hepatic, TB, epilepsy, nephritis

Design outcomes

Primary

MeasureTime frame
1. To study the total and relative excretion of radioactivity in urine and blood following a single 450 mg oral solution dose of PLGA loaded with rifampicin. 2. To study the distribution pattern of radiolabelled PLGA loaded with rifampicin by means of gamma camera scan at various time intervals. Timepoint: 0h 1h 2h 5h 7h 12h and 24h—

Secondary

MeasureTime frame
1. To study the pharmacokinetic parameters, such as AUC (0-â??), Cmax, half-life, tmax, of orally administered radiolabelled rifampicinTimepoint: 0h, 0.5h, 1h, 2, 6, 24, 48, 72, 96, 120, 144 and 168 h—

Countries

India

Contacts

Public ContactSamir Malhotra

PGIMER Chandigarh

smal.pgi@gmail.com01722755243

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026