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

November 23, 2020 updated by: World Medicine ILAC SAN. ve TIC. A.S.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ankara
      • Akyurt, Ankara, Turkey, 06970
        • Novagenix Drug R&D Center
    • Gaziantep
      • Sahinbey, Gaziantep, Turkey, 27000
        • Farmagen Ar-Ge Biyot. Ltd. Sti.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy Caucasian male subjects aged between 20 and 40 years,
  2. Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during the study period,
  3. Negative Covid-19 Rapid Test results and two Negative Covid-19 PCR test results,
  4. Negative alcohol breath test results,
  5. Normal physical examination at screening visit,
  6. 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,
  7. Ability to communicate adequately with the investigator himself or his representatives,
  8. Ability and agreement to comply with the study requirements,
  9. 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,
  10. Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest,
  11. 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),
  12. Understanding of the study and agreement to give a written informed consent according to section 20.3.
  13. Volunteer's compliance with isolation rules defined at study protocol

Exclusion Criteria:

  1. Who have atopic constitution or asthma or known allergy for lopinavir and ritonavir or any other ingredients of the products.
  2. 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.
  3. Baseline ECG should be performed at screening. Exclude subjects having a QTc > 440 ms
  4. 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),
  5. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
  6. 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.
  7. 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.
  8. 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).
  9. Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
  10. Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug.
  11. 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.
  12. Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study.
  13. History of allergic response to heparin.
  14. History of drug abuse.
  15. 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).
  16. Positive blood test for HBV, HCV and HIV.
  17. Who have relationship to the investigator.
  18. Who are not suitable to any of inclusion criteria.
  19. History of difficulty of swallowing.
  20. Intake of depot injectable solutions (including study medications) within 6 months before start of the study.
  21. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study.
  22. Special diet due to any reason, e.g. vegetarian.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Orvical-Kaletra-Orvical-Kaletra
In 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.
Drug: Lopinavir/Ritonavir 200 mg/50 mg Film Tablet
Lopinavir/Ritonavir film tablet containing 200 mg lopinavir and 50 mg ritonavir (World Medicine-Turkey).
Other Names:
  • Orvical 200 mg/50 mg Film Tablet
Drug: Lopinavir/Ritonavir 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)
Other Names:
  • Kaletra 200 mg/50 mg Film Coated Tablet
Experimental: Kaletra-Orvical-Kaletra-Orvical
In 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.
Drug: Lopinavir/Ritonavir 200 mg/50 mg Film Tablet
Lopinavir/Ritonavir film tablet containing 200 mg lopinavir and 50 mg ritonavir (World Medicine-Turkey).
Other Names:
  • Orvical 200 mg/50 mg Film Tablet
Drug: Lopinavir/Ritonavir 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)
Other Names:
  • Kaletra 200 mg/50 mg Film Coated Tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary PK End Points
Time Frame: 12 weeks
AUC0-tlast of lopinavir and ritonavir
12 weeks
Primary PK End Points
Time Frame: 13 weeks
Cmax of lopinavir and ritonavir
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
World Medicine ILAC SAN. ve TIC. A.S.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novagenix Bioanalytical Drug R&D Center
Farmagen Ar-Ge Biyot. Ltd. Sti

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Muradiye Nacak, MD,PhD, Farmagen Ar-Ge Biyot. Ltd. Sti

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 22, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NOV2020/01911
  • FARGE365 (Other Identifier: Farmagen)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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