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Bioequivalence Study of Linagliptin From Prevaglip 5 mg Tablets(Eva Pharma, Egypt) and Trajenta 5 mg Tablets (Boehringer Ingelheim International GmbH, Germany)

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ClinicalTrials.gov Identifier: NCT02857946
Recruitment Status : Completed
First Posted : August 5, 2016
Last Update Posted : August 5, 2016
Sponsor:
Collaborator:
Eva Pharma
Information provided by (Responsible Party):
Genuine Research Center, Egypt

Brief Summary:
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Linagliptin from Prevaglip 5 mg tablets(Eva pharma for Pharmaceuticals & Medical Appliances, Egypt) and Trajenta 5 mg tablets(Boehringer Ingelheim International GmbH, Germany) after a single oral dose administration of each to healthy adults under fasting conditions

Condition or disease Intervention/treatment Phase
Healthy Drug: Prevaglip (linagliptin) Drug: Trajenta (linagliptin) Phase 1

Detailed Description:

Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e.

The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.

A comprehensive final report will be issued upon the completion of the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Open Label, Randomized, Single Dose, Two-way Crossover Bioequivalence Study of Linagliptin From Prevaglip 5 mg Tablets (Eva Pharma, Egypt) and Trajenta 5 mg Tablets (Boehringer Ingelheim International GmbH, Germany)
Study Start Date : February 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Arm Intervention/treatment
Experimental: A Test
Test drug (Prevaglip) 1 tablet contains 5 mg linagliptin
Drug: Prevaglip (linagliptin)
1 tablet contains 5 mg linagliptin
Other Name: Prevaglip

Active Comparator: B Reference
Reference drug (Trajenta) 1 tablet contains 5 mg linagliptin
Drug: Trajenta (linagliptin)
1 tablet contains 5 mg linagliptin
Other Name: Trajenta




Primary Outcome Measures :
  1. Maximal measured plasma concentration (Cmax) [ Time Frame: Up to 72 hours post dose in each treatment period ]
    Serial blood samples for determination of study drug will be collected at 0.00, 0.33, 0.66, 1.0, 1.25, 1.5, 1.75, 2.00, 2.5, 3.0, 4, 6, 8, 12, 24, 48 and 72 hours


Secondary Outcome Measures :
  1. Time of the maximum plasma concentration (Tmax) [ Time Frame: Up to 72 hours post dose in each treatment period ]
    Serial blood samples for determination of study drug will be collected at 0.00, 0.33, 0.66, 1.0, 1.25, 1.5, 1.75, 2.00, 2.5, 3.0, 4, 6, 8, 12, 24, 48 and 72 hours



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male or female, age 18 to 55 years, inclusive.
  2. Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
  3. Medical demographics without evidence of clinically significant deviation from normal medical condition.
  4. Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
  5. Subject does not have allergy to the drugs under investigation.

Exclusion Criteria:

  1. Subjects with known allergy to the products tested.
  2. Subjects whose values of BMI were outside the accepted normal ranges.
  3. Female subjects who were pregnant, nursing or taking birth control pills.
  4. Medical demographics with evidence of clinically significant deviation from normal medical condition.
  5. Results of laboratory tests which are clinically significant.
  6. Acute infection within one week preceding first study drug administration.
  7. History of drug or alcohol abuse.
  8. Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
  9. Subject is on a special diet (for example subject is vegetarian).
  10. Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
  11. Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
  12. Subject has a history of severe diseases which have direct impact on the study.
  13. Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
  14. Subject intends to be hospitalized within 3 months after first study drug administration.
  15. Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02857946


Locations
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Egypt
Genuine Research Center GRC
Cairo, Egypt, 11757
Sponsors and Collaborators
Genuine Research Center, Egypt
Eva Pharma
Investigators
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Study Director: Ahmed Elshafeey, Ph.D. Pharma Genuine Research Center
Additional Information:
Publications:
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Responsible Party: Genuine Research Center, Egypt
ClinicalTrials.gov Identifier: NCT02857946    
Other Study ID Numbers: GRC/1/15/596
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action