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BioequivalencePhase 1OrvicalNCT04386876

Bioequivalence Study of Lopinavir/Ritonavir 200/50 mg Film Tablet (World Medicine Ilac, Turkey) Under Fasting Conditions

A Phase 1 study testing Lopinavir/Ritonavir 200 mg/50 mg Film Tablet and Lopinavir/Ritonavir 200 mg/50 mg Film Coated Tablet in people with Bioequivalence, run by World Medicine ILAC SAN. ve TIC. A.S. at 2 sites in Turkey (Türkiye).

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

A single dose of Reference product containing 200 mg lopinavir and 50 mg ritonavir fixed dose combination and a single dose of Test product containing 200 mg lopinavir and 50 mg ritonavir fixed dose combination or vice versa; administered with 240 mL of water at room temperature, in each period under fasting… Read more about this study

Who is it for?
Ages 20 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Bioequivalence
What is being tested?
Lopinavir/Ritonavir 200 mg/50 mg Film Tablet and Lopinavir/Ritonavir 200 mg/50 mg Film Coated Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesTurkey (Türkiye)
Study dates
30 Apr 2020to 11 Jun 2020
Phase
Phase 1
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 20 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy Caucasian male subjects aged between 20 and 40 years,
  • Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during the study period,
  • Negative Covid-19 Rapid Test results and two Negative Covid-19 PCR test results,
  • Negative alcohol breath test results,
  • Normal physical examination at screening visit,
  • Having the Body Mass Index ranged between 18.5-30 kg/m2 (see Appendix I) which is in the desirable range according to the age,
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  • Ability to communicate adequately with the investigator himself or his representatives,
  • Ability and agreement to comply with the study requirements,
  • Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 90 bpm,
  • Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest,
  • Laboratory results within normal range or clinically non-significant (CBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results in negative (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate),
  • Understanding of the study and agreement to give a written informed consent according to section 20.3.
  • Volunteer's compliance with isolation rules defined at study protocol

Who cannot join

  • Who have atopic constitution or asthma or known allergy for lopinavir and ritonavir or any other ingredients of the products.
  • Any history or presence of clinical relevance of cardiovascular (myocardial infarction/ ischaemia and/or QT prolongation etc.), neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria.
  • Baseline ECG should be performed at screening. Exclude subjects having a QTc > 440 ms
  • Symptomatic or asymptomatic orthostatic hypotension at screening or before the first drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10 mmHg occurs between sitting/supine to standing position subject will be excluded (if it deemed necessary by the investigator),
  • Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
  • Subjects who have given more than 400 mL blood within the last two months before the first drug administration and subjects who have participated to any drug research within the last two months before the first drug administration.
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  • Subjects suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgement.
  • Subjects who used any of prescribed systemic or topical medication (including OTC medication) within 2 weeks (or six elimination half lives of this medication, whichever is longer) before the initiation of the study (except single doses of analgesics which have no drug interaction with study product).
  • Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
  • Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug.
  • Subjects who regular consumed of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg methylxanthines per day.
  • Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study.
  • History of allergic response to heparin.
  • History of drug abuse.
  • History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or 10 units per week and/or positive alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits).
  • Positive blood test for HBV, HCV and HIV.
  • Who have relationship to the investigator.
  • Who are not suitable to any of inclusion criteria.
  • History of difficulty of swallowing.
  • Intake of depot injectable solutions (including study medications) within 6 months before start of the study.
  • Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study.
  • Special diet due to any reason, e.g. vegetarian.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Novagenix Drug R&D Center

    Akyurt, Ankara, 06970

  • Farmagen Ar-Ge Biyot. Ltd. Sti.

    Şahinbey, Gaziantep, 27000

Other trials in Turkey (Türkiye)

About this study

Official title: Randomized, Single Oral Dose,Two Treatment,Four-period,Full-replicated,Cross-over Trial to Assess the BE of Orvical 200 mg/50 mg FT in Comparison With Kaletra 200 mg/50 mg FT in Healthy Male Subjects Under Fasting Conditions

A single dose of Reference product containing 200 mg lopinavir and 50 mg ritonavir fixed dose combination and a single dose of Test product containing 200 mg lopinavir and 50 mg ritonavir fixed dose combination or vice versa; administered with 240 mL of water at room temperature, in each period under fasting conditions.

Read the detailed description

The subjects will me isolated at the dorm during 5 days before the dosing.

Conditions
Bioequivalence
Being tested
Lopinavir/Ritonavir 200 mg/50 mg Film Tablet, Lopinavir/Ritonavir 200 mg/50 mg Film Coated Tablet
Keywords
COVID-19 drug treatment, Ritonavir, Lopinavir, Antiviral Agents, Kaletra, Novagenix, Farmagen

What participants receive

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

  • Lopinavir/Ritonavir 200 mg/50 mg Film TabletDrug

    Also called Orvical 200 mg/50 mg Film Tablet

    Lopinavir/Ritonavir film tablet containing 200 mg lopinavir and 50 mg ritonavir (World Medicine-Turkey).

  • Lopinavir/Ritonavir 200 mg/50 mg Film Coated TabletDrug

    Also called Kaletra 200 mg/50 mg Film Coated Tablet

    Lopinavir/Ritonavir film coated tablet containing 200 mg lopinavir and 50 mg ritonavir(AbbVie Deutschland GmbH \& Co.-Germany)

Study groups in NCT04386876
Study groupRoleWhat they receive
Orvical-Kaletra-Orvical-KaletraExperimentalIn first and third periods of the study, participants received Orvical 200 mg/50 mg Film Tablet manufactured by World Medicine-Turkey. In second and fourth periods, they received Kaletra 200 mg/50 mg Film CoatedTablet manufactured by AbbVie Deutschland GmbH \& Co.-Germany. All periods were performed under fasting state.
Receives: Drug: Lopinavir/Ritonavir 200 mg/50 mg Film Tablet; Drug: Lopinavir/Ritonavir 200 mg/50 mg Film Coated Tablet
Kaletra-Orvical-Kaletra-OrvicalExperimentalIn first and third periods of the study, participants received Kaletra 200 mg/50 mg Film Coated Tablet manufactured by AbbVie Deutschland GmbH \& Co.-Germany. In second and fourth periods, they received Orvical 200 mg/50 mg Film Tablet manufactured by World Medicine-Turkey. All periods were performed under fasting state.
Receives: Drug: Lopinavir/Ritonavir 200 mg/50 mg Film Tablet; Drug: Lopinavir/Ritonavir 200 mg/50 mg Film Coated Tablet

What is being measured

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

  1. Primary PK End Points

    AUC0-tlast of lopinavir and ritonavir

    Measured: 12 weeks

  2. Primary PK End Points

    Cmax of lopinavir and ritonavir

    Measured: 13 weeks

Timeline

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

  1. First posted13 May 2020
  2. Study start30 Apr 2020
  3. Primary completion22 May 2020
  4. Study completion11 Jun 2020

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 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Single Oral Dose,Two Treatment,Four-period,Full-replicated,Cross-over
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04386876
Sponsor's protocol ID
NOV2020/01911
Other IDs
FARGE365
Acronym
Orvical
Status last verified
Nov 2020
First submitted
5 May 2020
Last updated
31 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lopinavir/Ritonavir 200 mg/50 mg Film Tablet and Lopinavir/Ritonavir 200 mg/50 mg Film Coated Tablet in people with Bioequivalence, run by World Medicine ILAC SAN. ve TIC. A.S. at 2 sites in Turkey (Türkiye).

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 13 inclusion and 22 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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Primary PK End Points (time frame: 12 weeks). 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 NCT04386876.

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 31 Dec 2020.

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