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Granulocyte Colony Stimulating Factor

Treatment Sequence II (DRL, B, A) for Pharmacokinetics

Phase 1
Waitlist Available
Research Sponsored by Dr. Reddy's Laboratories Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 105 days
Awards & highlights

Study Summary

This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~105 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 105 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC(0-inf)
AUC(0-t)
AUEC(0-t)
+2 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Treatment Sequence VI (B, DRL, A)Experimental Treatment3 Interventions
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, DRL_PG, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection.
Group II: Treatment Sequence V (B, A, DRL)Experimental Treatment3 Interventions
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, Pegfilgrastim Form A, DRL_PG. Each drug is administered as a single, 6 mg, subcutaneous injection.
Group III: Treatment Sequence IV (A, B, DRL)Experimental Treatment3 Interventions
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, Pegfilgrastim Form B, DRL_PG. Each drug is administered as a single, 6 mg, subcutaneous injection.
Group IV: Treatment Sequence III (A, DRL, B)Experimental Treatment3 Interventions
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, DRL_PG, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection.
Group V: Treatment Sequence II (DRL, B, A)Experimental Treatment3 Interventions
Patients will receive study drugs in the following cross-over sequence: DRL_PG, Pegfilgrastim Form B, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection.
Group VI: Treatment Sequence I (DRL, A, B)Experimental Treatment3 Interventions
Patients will receive study drugs in the following cross-over sequence: DRL_PG, Pegfilgrastim Form A, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Dr. Reddy's Laboratories LimitedLead Sponsor
234 Previous Clinical Trials
23,037 Total Patients Enrolled
1 Trials studying Pharmacokinetics
24 Patients Enrolled for Pharmacokinetics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers
2014. "A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02205320.
All > Health
~17 spots leftby May 2025
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