Healthy volunteers’ studies

Clinical Trial Experience in Healthy Volunteer Studies - Phase 1 and BE/BA

Triumpharma has successfully conducted more than 300 Phase I & BE/BA studies covering biotech/biosimilars/super-generics/small molecules, for major pharmaceutical companies worldwide.

These studies have been performed on both healthy subjects and patients, on various types of drugs and formulations including: modified release tablets/capsules, conventional tablets/capsules, complex and Long-Acting injectables (LAIs), infusion, Inhalers, ODS, CRF, thin films, In vitro skin permeation studies (IVPT), creams/lotions/Ointments, Orodispersible tablets (ODT), transdermal patches, and many others dosage forms, and for world global market submission including: Jordan, USA, Europe, Canada, Asia and MENA (the Middle East and North Africa) markets.

Triumpharma has demonstrated fast recruitment time and rate and very quick turnaround time for randomization and dosing.

Within BE/BA studies, Triumpharma has an expertise in conducting the following types of studies:

  • Fasting and Fed condition
  • Single and Multiple dose
  • Dose-Proportionality
  • Drug-Drug interaction (DDI)
  • Narcotic drugs (pain management)
  • Light Sensitive drugs
  • Short to Long confinement
  • Oral Inhalation – Pulmonary deposition & Therapeutic Equivalence
  • Pharmacokinetic interaction