Table 6 Clinical trial updates for comparative bioequivalence studies for freeze-dried formulations (https://clinicaltrials.gov/)

1

Phase II

A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects

Smallpox

Bavarian Nordic

Completed

(August 2012–October 2020)

NCT01668537

2

Phase I

Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects

Anovulation replacement therapy

Merck KGaA, Darmstadt, Germany

Completed (December 2014–July 2018)

NCT02317809

3

Phase III

Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial

Smallpox

Bavarian Nordic

Completed (October 2018–May 2021)

NCT03699124

4

Phase I

r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial

Recombinant Human growth hormone supplement

EMD Serono

Completed (December 2009–October 2013)

NCT01034735

5

Phase III

A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine)

Lot to lot consistency of human rotavirus vaccine

GlaxoSmithKline

Completed (October 2006–November 2016)

NCT00382772

6

–

Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High At-Risk Appalachian Patients Oral Cancer Survivors

Oral Cancer

Ohio State University Comprehensive Cancer Center

Completed (July 2012–February 2020)

NCT01504932

7

Phase I

A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor

hereditary angioedema

CSL Behring

Completed (January 2013–April 2013)

NCT01760343

8

Phase I

Pergoveris FD and Liquid China BE Study

Bioequivalence study for pituitary suppressed healthy premenopausal Chinese female

Merck Healthcare KGaA, Darmstadt, Germany

Currently Recruiting (May 2021)

NCT04899193