Bioequivalence Study of Lopinavir/Ritonavir 200/50 mg Film Tablet (World Medicine Ilac, Turkey) Under Fasting Conditions
NCT ID: NCT04386876
Last Updated: 2020-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2020-04-30
2020-06-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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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.
Lopinavir/Ritonavir 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 Tablet
Lopinavir/Ritonavir film coated tablet containing 200 mg lopinavir and 50 mg ritonavir(AbbVie Deutschland GmbH \& Co.-Germany)
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.
Lopinavir/Ritonavir 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 Tablet
Lopinavir/Ritonavir film coated tablet containing 200 mg lopinavir and 50 mg ritonavir(AbbVie Deutschland GmbH \& Co.-Germany)
Interventions
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Lopinavir/Ritonavir 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 Tablet
Lopinavir/Ritonavir film coated tablet containing 200 mg lopinavir and 50 mg ritonavir(AbbVie Deutschland GmbH \& Co.-Germany)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
Exclusion Criteria
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.
20 Years
40 Years
MALE
Yes
Sponsors
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Novagenix Bioanalytical Drug R&D Center
NETWORK
Farmagen Ar-Ge Biyot. Ltd. Sti
NETWORK
World Medicine ILAC SAN. ve TIC. A.S.
INDUSTRY
Responsible Party
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Principal Investigators
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Muradiye Nacak, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Farmagen Ar-Ge Biyot. Ltd. Sti
Locations
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Novagenix Drug R&D Center
Akyurt, Ankara, Turkey (Türkiye)
Farmagen Ar-Ge Biyot. Ltd. Sti.
Şahinbey, Gaziantep, Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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FARGE365
Identifier Type: OTHER
Identifier Source: secondary_id
NOV2020/01911
Identifier Type: -
Identifier Source: org_study_id