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| Name | Class |
|---|---|
| Ain Shams University | OTHER |
| Drug Research Centre, Cairo, Egypt | OTHER |
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A Randomized,Two-period, Crossover Study to Determine the Possibility of Drug-drug Interaction After Co-administration of Metformin and Daclatasvir Where Twenty Eligible Adult Subjects Will be Randomized to Receive Either Metformin Only and/or Metformin Co-administered With Daclatasvir to measure primary outcomes including pharmacokinetics parameters as: Maximum drug concentration in plasma(Cmax), Area under the Plasma concentration Versus Time Curve from time 0 to 12 hours(AUC0-12), Clearance(CL)
Study Design:
A randomized, one-way, single blinded, two-period, crossover study in adult human healthy egyptian volunteers
Methodology:
period (I): Group A:10 volunteers will receive 500 mg Metformin twice daily on day 1-4 then 1000mg metformin twice on day 5-7
GroupB:10 volunteers will receive 500 mg Metformin twice daily + Daclatasvir (DCV) 60 mg once daily on day 1-4 then 1000mg metformin twice daily+DCV 60 mg once daily on day 5-7
period (II): Group A:10 volunteers will receive 500 mg Metformin twice daily + Daclatasvir (DCV) 60 mg once daily on day 1-4 then 1000mg metformin twice daily+DCV 60 mg once daily on day 5-7
Group B:10 volunteers will receive 500 mg Metformin twice daily on day 1-4 then 1000mg metformin twice daily on day 5-7
All drug administration will be followed by 240 ml of water after at least 10 hours fasting prior to administration.
The two treatment periods will be separated by a one week washout period
Blood Sampling will be collected at a pre-dosing and at 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12 hours Urine samples will be collected for metformin analysis from 0 to 12 hours after drug administration.
A 75 g Oral glucose tolerance test(OGTT) will be carried out by ingestion of 75g glucose in 240ml water 2-hours post dosing and blood samples for determining glucose concentration during OGTTs were collected immediately before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, and 3 hours after glucose ingestion.
Blood samples will be collected from each volunteer prior to drug administration (blank) at the predetermined sampling intervals after drug administration in ethylene diamine tetra-acetic acid(kEDTA) containing tubes.
These samples will be centrifuged and the plasma harvested and stored at -80°C until assay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | Subjects administered Metformin 500mg(Glucophage tablets) twice daily till day(4) then Metformin 1000mg twice daily till day(7) |
|
| Metformin and Daclatasvir | Experimental | Subjects Coadministered Metformin 500mg(Glucophage tablets) twice daily and Daclatasvir 60mg tablets once daily till day (4) then Metformin 1000mg twice daily and Daclatasvir 60mg tablets once daily till Day(7) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin is used primarly in treatment of diabetes type II |
|
| Measure | Description | Time Frame |
|---|---|---|
| (AUC0→12) | Area under the plasma concentration-time curve measured in (nanogram(ng).hr/ml) | From first sampling interval(time zero) up to 12 hours |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC0→∞) | Area under the plasma concentration-time curve from time 0 to infinity measured in(ng.hr/ml) | From first sampling interval up to infinity |
| Area under the plasma concentration-time curve from time 0 to tau(AUC0→tau) | Area under the plasma concentration-time curve from time 0 to tau measured in(ng.hr/ml) | From first sampling interval up to dosing interval(Tau) |
| Maximum drug concentration in plasma at steady state(Cpss) | Maximum drug concentration in plasma at steady state measured in (ng/ml) | Time corresponding to maximum drug concentration in plasma at steady state |
| Half life( t½) of drug in plasma | Half life of drug measured in Hours(hr) | Up to 12 hours |
| Mean residence time of drug(MRT) | Mean residence time of drug in plasma measured in (hr) | From first sampling interval up to 12 hours |
| steady state Clearance of drug(CLss) | steady state Clearance of drug measured in (ml/min) | From first sampling interval up to 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose(BG) levels | Blood glucose levels measured in (mg/dl) | up to 3 hours |
| Area under the BG-time curve(AUG)0-3hr | Area under the BG-time curve measured in (mg.hr/dl) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Raslan | Ainshams university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drug research centre | Cairo | Egypt |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| C549273 | daclatasvir |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Twenty Eligible Adult Subjects Will be Randomized Equally into two Groups: A and B To Receive Either:
Group (A):10 subjects will receive 500 mg Metformin twice daily on day 1-4 then 1000mg metformin twice on day 5-7 Group (B):10 subjects will receive 500 mg co-administered daily with Daclatasvir 60 mg once daily on day 1-4 then 1000mg Metformin co-administered twice daily with Daclatasvir 60 mg once daily on day 5-7
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| Daclatasvir | Drug | Daclatsvir is a direct acting antiviral drug |
|
| Renal Clearance of drug(CLr) | Renal Clearance of drug measured in (ml/min) | From first sampling interval up to 12 hours |
| Cumulative amount of drug eliminated in urine (Ae) | Cumulative amount of drug eliminated in urine measured in (microgram(ug)/ml) | From first sampling interval up to 12 hours |
| Maximum excretion rate (Urate max) | Maximum excretion rate for the drug measured in (milligram(mg)/hr) | From first sampling interval up to 12 hours |
| up to 3 hours |
| Maximum Glucose concentration(Gmax) | Maximum Glucose concentration measured in (mg/dl) | up to 3 hours |
| D004700 | Endocrine System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |