Status:
COMPLETED
Bioequivalence Study to Compare Metformin / Vildagliptin Versus Galvumet®
Lead Sponsor:
Reseach Laboratory of Clinical and Experimental Pharmacology
Collaborating Sponsors:
La Société Arabe des Industries Pharmaceutiques-Tunisie
Centre National Chalbi Belkahia de Pharmacovigilance-Tunisie
Conditions:
Fed Conditions
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The aim of this study is to assess bioequivalence between a single oral dose from the test product Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufac...
Detailed Description
The aim of this study is to assess bioequivalence between a single oral dose from the test product Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufac...
Eligibility Criteria
Inclusion
- A. The subject is aged between eighteen to fifty years (18 - 50), both inclusive.
- B. The subject is within the limits for his height \& weight as defined by the body mass index (BMI) range (18.5 - 30.0 Kg/m2).
- C. The subject is able to understand and willing to sign the Informed Consent Form.
- D. The subject has completed his Coronavirus 19 vaccination schedule. E. The subject is willing to undergo the necessary medical examinations pre- during \& post-study.
- F. There is no evidence of psychiatric disorder, antagonistic personality, and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- G. The results of medical history, physical examination, vital signs, conducted medical laboratory tests \& ECG recording are normal as determined by the investigator.
- H. The subject tested negative for Hepatitis B (HBsAg) and Hepatitis C (HCVAb). I. For female subjects: negative pregnancy test and the woman is using two reliable contraception methods and should be non-lactating.
- Non-inclusion Criteria:
- A. The subject is a heavy smoker (more than 10 cigarettes per day). B. The subject has a history of or concurrent abuse of alcohol. C. The subject has a history of or concurrent abuse of illicit drugs. D. The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
- E. The subject is vegetarian. F. The subject has suffered an acute illness within seven (7) days before first dosing (declared before inclusion).
- G. The subject has been hospitalized within three (3) months before the study. H. The subject has taken a prescription medication within two weeks or even an over-the-counter product (OTC) within seven (7) days before first dosing.
- I. The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before first dosing (declared before inclusion).
- J. The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases.
- K. The subject has been participating in any clinical study (e.g. PKs, BA and BE studies) within the last 80 days prior to the present study.
- L. The subject has donated blood within 80 days before first dosing.
Exclusion
- A. The subject has suffered an acute illness within seven (7) days before dosing (declared after inclusion).
- B. The subject has been hospitalized during the study. C. The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two (2) days before dosing and until 12 Hrs after dosing in both study periods.
- D. The subject has taken a prescription medication within two (2) weeks or even an OTC within seven (7) days before first dosing and any time during the study unless otherwise judged acceptable by the investigator.
- E. The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before dosing (declared after inclusion) and any time during the study.
- F. The subject underwent a radiological examination with an injection of Iodinated Contrast Media within 48 hours before first dosing.
- G. The subject has a positive Covid-19 rapid test.
Key Trial Info
Start Date :
May 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06073600
Start Date
May 20 2022
End Date
November 13 2022
Last Update
October 25 2023
Active Locations (1)
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1
Centre National Chalbi Belkahia de Pharmacovogilance
Tunis, Tunisia, 1006