Treatment Sequence I (DRL, A, B) 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

All Individual Drugs Already Approved

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 105 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC(0-inf)

AUC(0-t)

AUEC(0-t)

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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