Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson&Jonson", Russia)

NCT04268472 | Completed DMC

• 1 other identifier: GP30101-P4-11
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson\&Jonson", Russia)

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (2)

• C(max)

  Pharmacokinetics by Assessment of Observed Maximum Plasma Concentration (Cmax)

  -35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose

• AUC(0-t)

  Pharmacokinetics by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t)

  -35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose

Secondary Outcomes (3)

• T(max)

  -35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose

• T(1/2)

  -35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose

• K(e)

  -35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose

Study Arms (2)

TR Sequence

EXPERIMENTAL

In first Intervention period subjects was administered test medecine (GP30101) and in seconde Intervention period subjects was administered reference medecine (Prezista)

Drug: GP30101; Drug: Prezista®

RT Sequence

EXPERIMENTAL

In first Intervention period subjects was administered reference medecine (Prezista) and in seconde Intervention period subjects was administered test medecine (GP30101)

Drug: Prezista®; Drug: GP30101

Interventions

GP30101 DRUG

Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer

Also known as: First aIntervention Period

TR Sequence

Prezista® DRUG

Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer

Also known as: First Intervention Period

RT Sequence

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent form.
• Male aged 18 to 45 years.
• Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
• Body mass index between 18,5 and 30 kg/m2, with body weight 60-100 kg
• Consent to comply with an adequate method of effective contraception throughout the study.
• The consent of volunteers to all restrictions imposed during the study.
• Russian Federation Citizens

You may not qualify if:

• History of allergic problems/events.
• Hypersensitivity to heparin, darunavir or any of the excipients of the drugs studied.
• Any acute and chronic diseases, including but not limited to cardiovascular system diseases, bronchopulmonary diseases, neuroendocrine systems diseases, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
• Positive testing for hepatitis C (antibodies) or hepatitis B (surface antigen), HIV (antibodies to HIV-1/2), syphilis (antibodies to Treponema pallidum).
• The WHO norms deviations of the heart rate (60-89), Sistolic BP (100-130 mm Hg), Diatolic BP (60-89 mm Hg), respiratory rate (12-20), body temperature (35.7 - 37.6 °C).
• Abnormal ECG during screening.
• Inaccessible veins of the upper extremities, vein thrombosis, thrombophlebitis in the anamnesis or in the family history of the next of kin, "compromised" veins due to frequent previous venipuncture.
• Psychiatric disorders, history of epilepsy and seizures.
• Surgical interventions on the gastrointestinal tract (except appendectomy).
• Acute infectious diseases in less than 4 weeks before the start of the study.
• Regular medication use (intake) less than 2 weeks before the start of the study.
• Significant loss of blood within 3 months prior to screening, including but not limited to blood donation or extended surgery or trauma resulting in the blood loss.
• History of alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).
• Positive test results for alcohol or drug use.
• Nicotine addiction, regular use of tobacco, including all types of electronic cigarettes, less than 6 months prior to screening.

Sponsors & Collaborators

• Geropharm: lead

Study Sites (1)

Yarosslavl Clinical Hospital #3

Yaroslavl, Russia

Location

MeSH Terms

Interventions

Darunavir

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover Assignment two-way crossover

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 13, 2020
• Study Start: June 6, 2019
• Primary Completion: September 6, 2019
• Study Completion: September 6, 2019
• Last Updated: July 22, 2024

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)