Phase 1 trial of novel nanoformulation of antitubercular drugs in healthy volunteers

Phase 1 trial of poly (lactide-co-glycolide( (PLG) nanoparticles encapsulating antitubercular drugs (isoniazid, rifmapicin, pyrazinamide and ethambutol).

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/10/007356

Enrollment

Registered

2016-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Nanoformulation of 4 drugs single dose: Dose: Multiple doses starting at 1/10th therapeutic dose. Frequency and duration: Single dose only Route of administration: Oral. Intervention2:

Eligibility

Inclusion criteria

Inclusion criteria: Within 20% of ideal weight Willing to give written informed consent Medical history, physical examination, routine hematology, clinical chemistry, HIV, urinalysis, visual acuity and stool examination for occult blood

Exclusion criteria

Exclusion criteria: Smokers, alcoholics or taking any drugs of abuse Known contraindication to any of the study drugs HIV / HBsAg positive individuals Participated in any IND study within the previous 6 months or in a confirmatory trial in the previous 3 months

Design outcomes

Primary

Measure	Time frame
SafetyTimepoint: 1,2,7,30 days	—

Secondary

Measure	Time frame
PKTimepoint: 0,30 min, 1, 2, 4, 8, 12, 24, 28, 32, 36, 48, hours and twice daily thereafter for up to 7 days	—

Countries

India

Contacts

Public ContactNusrat Shafiq

PGIMER

smal.pgi@gmail.com01722755243

Outcome results