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BioequivalenceNCT04268472

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

A study testing GP30101 and Prezista® in people with Bioequivalence, run by Geropharm at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson\&Jonson", Russia) Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Bioequivalence
What is being tested?
GP30101 and Prezista®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteRussia
Study dates
6 Jun 2019to 6 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.
  • Participation in a clinical trial of any drugs (including experimental) or experimental medical devices for 3 months or 5 half-lives, whichever is longer, before the study.
  • Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours before the start of the study.
  • Any diet (for example, vegetarian, fasting, etc.) or lifestyle (including night work and extreme physical activity) that may interfere with the study.
  • Taking medications that have a pronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) less than 30 days before the start of the study.
  • Volunteers who are obvious or likely, according to the investigator, are unable to understand and evaluate the information on this study as part of the process of signing informed consent, in particular regarding the expected risks and possible discomfort.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Yarosslavl Clinical Hospital #3

    Yaroslavl

Other trials in Russia

About this study

Official title: Bioequivalence Study of GP30101 Film-coated Tablets (LLC "GEROPHARM", Russia) 800 mg Versus Prezista® (Jonson&Jonson, Russia) Film-coated Tablets 800 mg in Healthy Volunteers Under Fed Conditions

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

Read the detailed description

Study to evaluate the pharmacokinetic parameters, relative bioavailability and bioequivalence of drugs containing darunavir - GP30101 and Prezista® in healthy volunteers after single orally administered dose, under fed conditions A comparative analysis of adverse events aditionally conducted in this study.

Conditions
Bioequivalence
Being tested
GP30101, Prezista®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GP30101Drug

    Also called First aIntervention Period

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

  • Prezista®Drug

    Also called First Intervention Period

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

  • GP30101Drug

    Also called Second Intervention Period

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

  • Prezista®Drug

    Also called Second Intervention Period

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

Study groups in NCT04268472
Study groupRoleWhat they receive
TR SequenceExperimentalIn first Intervention period subjects was administered test medecine (GP30101) and in seconde Intervention period subjects was administered reference medecine (Prezista)
Receives: Drug: GP30101; Drug: Prezista®
RT SequenceExperimentalIn first Intervention period subjects was administered reference medecine (Prezista) and in seconde Intervention period subjects was administered test medecine (GP30101)
Receives: Drug: Prezista®; Drug: GP30101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. C(max)

    Pharmacokinetics by Assessment of Observed Maximum Plasma Concentration (Cmax)

    Measured: -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

  2. AUC(0-t)

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

    Measured: -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)

  1. T(max)

    Pharmacokinetics by Assessment of Time of Maximum concentration observed (T(max)

    Measured: -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

  2. T(1/2)

    Pharmacokinetics by Assessment of elimination half-life T(1/2)

    Measured: -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

  3. K(e)

    Pharmacokinetics by Assessment of elimination rate constant

    Measured: -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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2020
  2. Study start6 Jun 2019
  3. Primary completion6 Sep 2019
  4. Study completion6 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Crossover Assignment two-way crossover
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04268472
Sponsor's protocol ID
GP30101-P4-11
Status last verified
Feb 2020
First submitted
10 Feb 2020
Last updated
22 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing GP30101 and Prezista® in people with Bioequivalence, run by Geropharm at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

C(max) (time frame: -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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04268472.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.

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