Back to resultsEvaluation of Drug Interactions of Saxagliptin With Sildenafil in Healthy Volunteers
Primary Purpose
Diabetes Mellitus, Type 2, Erectile Dysfunction With Diabetes Mellitus, Drug Interaction
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Saxagliptin 5mg
Sildenafil 50 mg
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Age 18-45 years.
- Ideal weight within the normal range according to accepted life tables.
- Non-contributory history and normal physiological examination.
- Laboratory data within normal limits.
- Performance and compliance.
- The subjects should be without known history of alcohol or drug abuse problems and should preferably be non-smokers.
- The volunteers will be asked to provide a complete medical history, and complete a physical examination, laboratory tests (hematology, clinical chemistry, urinalysis serology (including hepatitis B surface antigen, anti-hepatitis C virus and antihuman immunodeficiency virus antibody).
Exclusion Criteria:
- A known hypersensitivity to the drug.
- Gastrointestinal diseases.
- Auto immune diseases.
- Renal diseases or dysfunction.
- Cardiovascular disease of any type.
- Pancreatic disease including diabetes.
- Hepatic disease.
- Hematological, osteopathic, or pulmonary disease.
- History of alcoholism or drug abuse.
- Serious Psychological illness.
- Positive HIV-I.
- Smoking (if including they should be identified).
- Abnormal (out of range) laboratory values.
- Subject who have taken any medication (Rx or OTC) less than two weeks of the trials starting date.
- Subject who have donated blood or who have been in multiple dosing studies requiring a large volume of blood (more than 500 ml) to be drawn within six weeks preceding the start of the trials.
- Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
- Treatment with any known enzyme-inducing / inhibiting agents within 30 days prior to the start of the study and throughout the study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy volunteer
Arm Description
Day 1: Sildenafil 50 mg single dose Day 2-Day 8: Washout period Day 9-12: Saxagliptin 5 mg Once/day Day 13: Sildenafil 50 mg+ Saxagliptin 5 mg
Outcomes
Primary Outcome Measures
Cmax
Maximum Plasma Concentration
(AUC0→∞)
Area Under Curve Infinity
(AUC0→t)
Area Under the Curve
tmax;
Time to reach Maximum concentration
T½
Drug half Life
Ke
Elimination Rate
ka
Absorption Rate
Blood Pressure
changes in Systolic and Diastolic Blood Pressure from normal range
Heart Rate
Changes in heart rate from normal range
Secondary Outcome Measures
Full Information
NCT ID
NCT04170790
First Posted
November 14, 2019
Last Updated
November 19, 2019
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT04170790
Brief Title
Evaluation of Drug Interactions of Saxagliptin With Sildenafil in Healthy Volunteers
Official Title
Evaluation of Drug Interactions of Saxagliptin With Sildenafil in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with diabetes are three times more likely to develop erectile dysfunction (ED), and longer duration of diabetes is strongly associated with ED. The possibility of pharmacokinetic interactions may occur as the two drugs are metabolized by hepatic CYP3A4 and their co administration may affect their plasma concentrations. the aim of work is to investigate the effect of sildenafil a CYP3A4 substrate and inhibitor on the pharmacokinetics and safety of Saxagliptin, a CYP3A4 substrate Subjects and Methods: Eighteen healthy volunteers will be recruited in Sequential, single center study to determine pharmacokinetic parameters of Saxagliptin, and sildenafil,(AUC0→∞), (AUC0→t); Cmax; tmax; t½, k; ka) will be measured using validated LC-MS/MS method. Therapeutic doses will be given to volunteers as follows: Sildenafil 50 mg single dose on day 1, then washout period from day 2 till day 8. Saxagliptin 5 mg once/day will be given from day 9 till day 12, then on day 13 the two drugs will be co-administered. Blood samples (5ml) for pharmacokinetic analysis will be collected on days 1 and 13 for Sildenafil as well as on days 12 and 13 for Saxagliptin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Erectile Dysfunction With Diabetes Mellitus, Drug Interaction
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Eighteen healthy volunteers will be recruited in Sequential, single center study to determine pharmacokinetic parameters of Saxagliptin, and sildenafil,(AUC0→∞), (AUC0→t); Cmax; tmax; t½, k; ka) will be measured using validated LC-MS/MS method. Therapeutic doses will be given to volunteers as follows: Sildenafil 50 mg single dose on day 1, then washout period from day 2 till day 8. Saxagliptin 5 mg once/day will be given from day 9 till day 12, then on day 13 the two drugs will be co-administered. Blood samples (5ml) for pharmacokinetic analysis will be collected on days 1 and 13 for Sildenafil as well as on days 12 and 13 for Saxagliptin
Masking
None (Open Label)
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteer
Arm Type
Experimental
Arm Description
Day 1: Sildenafil 50 mg single dose Day 2-Day 8: Washout period Day 9-12: Saxagliptin 5 mg Once/day Day 13: Sildenafil 50 mg+ Saxagliptin 5 mg
Intervention Type
Drug
Intervention Name(s)
Saxagliptin 5mg
Other Intervention Name(s)
Onglyza
Intervention Description
Saxagliptin 5mg oral tablet
Intervention Type
Drug
Intervention Name(s)
Sildenafil 50 mg
Other Intervention Name(s)
Viagra
Intervention Description
Sildenafil 50 mg Oral Tablet
Primary Outcome Measure Information:
Title
Cmax
Description
Maximum Plasma Concentration
Time Frame
pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Title
(AUC0→∞)
Description
Area Under Curve Infinity
Time Frame
pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Title
(AUC0→t)
Description
Area Under the Curve
Time Frame
pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Title
tmax;
Description
Time to reach Maximum concentration
Time Frame
pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Title
T½
Description
Drug half Life
Time Frame
pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Title
Ke
Description
Elimination Rate
Time Frame
pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Title
ka
Description
Absorption Rate
Time Frame
pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Title
Blood Pressure
Description
changes in Systolic and Diastolic Blood Pressure from normal range
Time Frame
measured before dosing and at 2, 4, 6, 8, and 10 hours after drug administration on each day of blood sampling
Title
Heart Rate
Description
Changes in heart rate from normal range
Time Frame
measured before dosing and at 2, 4, 6, 8, and 10 hours after drug administration on each day of blood sampling
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-45 years.
Ideal weight within the normal range according to accepted life tables.
Non-contributory history and normal physiological examination.
Laboratory data within normal limits.
Performance and compliance.
The subjects should be without known history of alcohol or drug abuse problems and should preferably be non-smokers.
The volunteers will be asked to provide a complete medical history, and complete a physical examination, laboratory tests (hematology, clinical chemistry, urinalysis serology (including hepatitis B surface antigen, anti-hepatitis C virus and antihuman immunodeficiency virus antibody).
Exclusion Criteria:
A known hypersensitivity to the drug.
Gastrointestinal diseases.
Auto immune diseases.
Renal diseases or dysfunction.
Cardiovascular disease of any type.
Pancreatic disease including diabetes.
Hepatic disease.
Hematological, osteopathic, or pulmonary disease.
History of alcoholism or drug abuse.
Serious Psychological illness.
Positive HIV-I.
Smoking (if including they should be identified).
Abnormal (out of range) laboratory values.
Subject who have taken any medication (Rx or OTC) less than two weeks of the trials starting date.
Subject who have donated blood or who have been in multiple dosing studies requiring a large volume of blood (more than 500 ml) to be drawn within six weeks preceding the start of the trials.
Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
Treatment with any known enzyme-inducing / inhibiting agents within 30 days prior to the start of the study and throughout the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rania Y Mansour, MD
Phone
0201000350066
Email
rania.mansour@mehy-eg.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
36214883
Citation
Mansour RY, ElBorolossy R, Shaheen SM, Sabri NA. Evaluation of drug interactions of saxagliptin with sildenafil in healthy volunteers. Eur J Clin Pharmacol. 2022 Dec;78(12):1935-1944. doi: 10.1007/s00228-022-03397-w. Epub 2022 Oct 10.
Results Reference
derived
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Evaluation of Drug Interactions of Saxagliptin With Sildenafil in Healthy Volunteers
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