# Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases

> **NCT01963143** · PHASE3 · COMPLETED · sponsor: **Bio Products Laboratory** · enrollment: 48 (actual)

## Conditions studied

- Primary Immune Deficiency Disorders
- Common Variable Immunodeficiency
- X-linked Agammaglobulinaemia
- Hyper-IgM Syndrome

## Interventions

- **BIOLOGICAL:** Gammaplex (5%)
- **BIOLOGICAL:** Gammaplex 10

## Key facts

- **NCT ID:** NCT01963143
- **Lead sponsor:** Bio Products Laboratory
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2014-02
- **Primary completion:** 2016-01
- **Final completion:** 2016-05
- **Target enrollment:** 48 (ACTUAL)
- **Last updated:** 2017-03-29


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01963143

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01963143, "Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases". Retrieved via AI Analytics 2026-07-01 from https://api.ai-analytics.org/clinical/NCT01963143. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*