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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386876
Recruitment Status : Active, not recruiting
First Posted : May 13, 2020
Last Update Posted : May 15, 2020
Sponsor:
Collaborators:
Novagenix Bioanalytical Drug R&D Center
Farmagen Ar-Ge Biyot. Ltd. Sti
Information provided by (Responsible Party):
World Medicine ILAC SAN. ve TIC. A.S.

Brief 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 conditions.

Condition or disease Intervention/treatment Phase
Bioequivalence Drug: Lopinavir 200Mg/Ritonavir 50Mg FT Test Drug: Lopinavir 200Mg/Ritonavir 50Mg FT Reference Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single Oral Dose,Two Treatment,Four-period,Full-replicated,Cross-over
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : April 30, 2020
Estimated Primary Completion Date : May 22, 2020
Estimated Study Completion Date : June 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lopinavir/ritonavir Test
Orvical 200 mg/50 mg Film Tablet manufactured by World Medicine Ilaç San. ve Tic., Turkey.
Drug: Lopinavir 200Mg/Ritonavir 50Mg FT Test
Orvical 200 mg/50 mg Film Tablet" containing 200 mg lopinavir and 50 mg ritonavir (World Medicine-Turkey).
Other Name: Orvical 200 mg/50 mg FT

Active Comparator: Lopinavir/ritonavir Reference
Kaletra 200 mg/50 mg Film CoatedTablet manufactured by AbbVie Deutschland GmbH & Co. -Germany
Drug: Lopinavir 200Mg/Ritonavir 50Mg FT Reference
Kaletra 200 mg/50 mg Film CoatedTablet manufactured by AbbVie Deutschland GmbH & Co. -Germany
Other Name: Kaletra 200 mg/50 mg FT




Primary Outcome Measures :
  1. Primary PK End Points [ Time Frame: 12 weeks ]
    AUC0-tlast of lopinavir and ritonavir

  2. Primary PK End Points [ Time Frame: 13 weeks ]
    Cmax of lopinavir and ritonavir



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386876


Locations
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Turkey
Novagenix Drug R&D Center
Akyurt, Ankara, Turkey, 06970
Farmagen Ar-Ge Biyot. Ltd. Sti.
Sahinbey, Gaziantep, Turkey, 27000
Sponsors and Collaborators
World Medicine ILAC SAN. ve TIC. A.S.
Novagenix Bioanalytical Drug R&D Center
Farmagen Ar-Ge Biyot. Ltd. Sti
Investigators
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Principal Investigator: Muradiye Nacak, MD,PhD Farmagen Ar-Ge Biyot. Ltd. Sti
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Responsible Party: World Medicine ILAC SAN. ve TIC. A.S.
ClinicalTrials.gov Identifier: NCT04386876    
Other Study ID Numbers: NOV2020/01911
FARGE365 ( Other Identifier: Farmagen )
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by World Medicine ILAC SAN. ve TIC. A.S.:
COVID-19 drug treatment
Ritonavir
Lopinavir
Antiviral Agents
Kaletra
Novagenix
Farmagen
Additional relevant MeSH terms:
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Ritonavir
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors