Trial · NCT02634073
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24]) | Day 1 to Day 3 in each treatment period | PK Summary Population: defined as participants who had valid lamivudine PK parameter estimates from both reference and test treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | hour (h)*microgram (mcg)/milliliter (mL) | GEOMETRIC_MEAN |
| PRIMARY | Plasma Lamivudine Maximum Observed Concentration (Cmax), Concentration at 24 Hour (h) Post-dose (C24) and Last Measurable Concentration (Ct) | Day 1 to Day 3 in each treatment period | mcg/mL | GEOMETRIC_MEAN | |
| PRIMARY | Lamivudine Elimination Half-life in Plasma (t1/2) | Day 1 to Day 3 in each treatment period | PK Summary Population | Hour (Hr) | GEOMETRIC_MEAN |
| PRIMARY | Plasma Lamivudine Apparent Oral Clearance (CL/F) | Day 1 to Day 3 in each treatment period | PK Summary Population | Liter (L)/hr | GEOMETRIC_MEAN |
| PRIMARY | Time to Observed Maximum Lamivudine Plasma Concentration (Tmax), Time of Last Measurable Plasma Concentration (Tlast) and Absorption Lag Time in Plasma (Tlag) | Day 1 to Day 3 in each treatment period | Hr | MEDIAN | |
| SECONDARY | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAE) | Up to 5 Weeks | Safety Population: defined as all participants who enrolled into the study and received at least one dose of study drug. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Pulse Rate | Baseline and up to 5 weeks | Safety Population.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Beats/min | MEAN |
| SECONDARY | Change From Baseline in Body Temperature | Baseline and up to 5 weeks | Safety Population | Degree centigrade | MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline and up to 5 weeks | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | millimeter of mercury (mmHg) | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Laboratory Abnormality Grade | Up to Week 5 | Safety Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Erythrocytes | Baseline and up to 5 weeks | Safety Population | 10^12 cells/L | MEAN |
| SECONDARY | Change From Baseline in Hematocrit | Baseline and up to 5 weeks | Safety Population | Fraction of 1 | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin | Baseline and up to 5 weeks | Safety Population | G/L | MEAN |
| SECONDARY | Change From Baseline in Mean Corpuscular Hemoglobin (MCH) | Baseline and up to 5 weeks | Safety Population | Picogram | MEAN |
| SECONDARY | Change From Baseline in Mean Corpuscular Volume (MCV) | Baseline and up to 5 weeks | Safety Population | Femtoliter | MEAN |
| SECONDARY | Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils | Baseline and up to 5 weeks | Safety Population | 10^9 cells/L | MEAN |
| SECONDARY | Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium | Baseline and up to 5 weeks | Safety Population | millimole (mmol)/L | MEAN |
| SECONDARY | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphates | Baseline and up to 5 weeks | Safety Population | Unit (U)/L | MEAN |
| SECONDARY | Change From Baseline in Creatinine, Total Bilirubin and Direct Bilirubin | Baseline and up to 5 weeks | Safety Population | micromole (umol)/L | MEAN |
| SECONDARY | Change From Baseline in Albumin | Baseline and up to 5 weeks | Safety Population | G//L | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02634073/outcomes