Bioequivalence Study to Compare Metformin / Vildagliptin Versus Galvumet®

NCT06073600 | Completed Phase 1 DMC

• 1 other identifier: CNPVBE02-2022
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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) manufactured by Pharmaceutical Arab Industries Society, Tunisia versus the reference product Galvumet® tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Novartis. This study also aims to monitor the safety of the subjects. This study is an open label, randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover study with a washout interval of at least one week between dosing. Eighteen (18) Tunisian subjects will be enrolled for this study. Subjects will be healthy volunteers, adults, aged between eighteen to fifty (18-50) years, (both inclusive), within the accepted limits for body height \& weight and meeting the selection criteria for this study.

Conditions

Fed Conditions

Keywords

Bioequivalence; Metformin; Vildagliptin; Phase 1

Outcome Measures

Primary Outcomes (2)

• Cmax

  obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: Cmax.

  2 - 4 Hours

• AUC 0 - t

  obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: AUC 0 - t.

  0 - 24 Hours

Secondary Outcomes (3)

• Tmax

  2 - 4 Hours

• T half

  7 days

• K elimination (λz)

  7 days

Study Arms (2)

First group of healthy volunteers

EXPERIMENTAL

The first group of healthy volunteers, defined by randomization

Drug: Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®); Drug: Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg)

Second group of healthy volunteers

ACTIVE COMPARATOR

The second group of healthy volunteers, defined by randomization

Drug: Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®); Drug: Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg)

Interventions

Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®) DRUG

The subjects randomly received a single oral administration of Metformin / Vildagliptin Film Coated Tablets (1000 mg / 50 mg).

Also known as: Galvumet®

First group of healthy volunteers; Second group of healthy volunteers

Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg) DRUG

The subjects randomly received a single oral administration of Metformin / Vildagliptin Film Coated Tablets (1000 mg / 50 mg).

Also known as: BiGalvine

First group of healthy volunteers; Second group of healthy volunteers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Reseach Laboratory of Clinical and Experimental Pharmacology: lead
• La Société Arabe des Industries Pharmaceutiques-Tunisie: collaborator
• Centre National Chalbi Belkahia de Pharmacovigilance-Tunisie: collaborator

Study Sites (1)

Centre National Chalbi Belkahia de Pharmacovogilance

Tunis, 1006, Tunisia

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Sameh Trabelsi

  Research Laboratory of Clinical and experimental Pharmacology LR16SP02

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this bioequivalence study, the bioanalysis, the pharmacokinetics and the statistical analysis will be blind.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor in Pharmacology

Model Details: This study is an open label, randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover study with a washout interval of at least one week between dosing.

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: October 10, 2023
• Study Start: May 20, 2022
• Primary Completion: September 9, 2022
• Study Completion: November 13, 2022
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)