Trials / Completed
CompletedNCT04386876
Bioequivalence Study of Lopinavir/Ritonavir 200/50 mg Film Tablet (World Medicine Ilac, Turkey) Under Fasting Conditions
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- World Medicine ILAC SAN. ve TIC. A.S. · Industry
- Sex
- Male
- Age
- 20 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Detailed description
The subjects will me isolated at the dorm during 5 days before the dosing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lopinavir/Ritonavir 200 mg/50 mg Film Tablet | Lopinavir/Ritonavir film tablet containing 200 mg lopinavir and 50 mg ritonavir (World Medicine-Turkey). |
| 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) |
Timeline
- Start date
- 2020-04-30
- Primary completion
- 2020-05-22
- Completion
- 2020-06-11
- First posted
- 2020-05-13
- Last updated
- 2020-12-31
Locations
2 sites across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04386876. Inclusion in this directory is not an endorsement.