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| ID | Type | Description | Link |
|---|---|---|---|
| FARGE365 | Other Identifier | Farmagen |
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| Name | Class |
|---|---|
| Novagenix Bioanalytical Drug R&D Center | NETWORK |
| Farmagen Ar-Ge Biyot. Ltd. Sti | NETWORK |
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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.
The subjects will me isolated at the dorm during 5 days before the dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orvical-Kaletra-Orvical-Kaletra | Experimental | 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. |
|
| Kaletra-Orvical-Kaletra-Orvical | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/Ritonavir 200 mg/50 mg Film Tablet | Drug | Lopinavir/Ritonavir film tablet containing 200 mg lopinavir and 50 mg ritonavir (World Medicine-Turkey). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary PK End Points | AUC0-tlast of lopinavir and ritonavir | 12 weeks |
| Primary PK End Points | Cmax of lopinavir and ritonavir | 13 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muradiye Nacak, MD,PhD | Farmagen Ar-Ge Biyot. Ltd. Sti | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novagenix Drug R&D Center | Akyurt | Ankara | 06970 | Turkey (Türkiye) | ||
| Farmagen Ar-Ge Biyot. Ltd. Sti. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 17, 2020 | May 30, 2020 |
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Single Oral Dose,Two Treatment,Four-period,Full-replicated,Cross-over
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|
| Lopinavir/Ritonavir 200 mg/50 mg Film Coated Tablet | Drug | Lopinavir/Ritonavir film coated tablet containing 200 mg lopinavir and 50 mg ritonavir(AbbVie Deutschland GmbH & Co.-Germany) |
|
|
| Şahinbey |
| Gaziantep |
| 27000 |
| Turkey (Türkiye) |
| ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2020 | May 30, 2020 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| D009040 | Motion Pictures |
| C558899 | lopinavir-ritonavir drug combination |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
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