The Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT Under Fed Conditions

NCT06244407 | Unknown Phase 1

• 1 other identifier: BE23-014
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions

Conditions

Healthy Volunteer

Keywords

Vildagliptin and Metformin Hydrochloride 50/1000 mg FCT; Bioequivalence Study

Outcome Measures

Primary Outcomes (1)

• Plasma Area Under the Curve (AUC(0 to 36hr)) for Vildagliptin and Metformin

  Plasma Area Under the Curve of Vildagliptin and Metformin

  Through 36 Hours Post Dose]

Study Arms (2)

Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated tablet

EXPERIMENTAL

Participants first received Vildagliptin and metformin HCl 50/1000 mg 1 tablet (Test product) in a fasting state. After a washout period of 7 days, they then recieved Galvus Met® 1 tablet (Reference product) in a fed state.

Drug: Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets

Galvus Met®

ACTIVE COMPARATOR

Participants first received Galvus Met® 1 tablet (Reference product) in a fed state. After a washout period of 7 days, they then recieved Vildagliptin and metformin HCl 50/1000 mg (Test product) in a fed state.

Drug: Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets

Interventions

Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets DRUG

Vildagliptin and Metformin Hydrochloride 50/1000 mg Film-coated Tablets

Also known as: Vildagliptin and Metformin Hydrochloride 50/1000 mg Film-coated Tablets

Galvus Met®; Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Thai male or female subjects between the ages of 18 to 55 years
• Body mass index between 18.5 to 30.0 kg/m2
• Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
• Non-pregnant woman (negative pregnancy test) and not currently breast feeding
• Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1:
• Postmenopausal for at least 1 year
• Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
• Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2.
• Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study

You may not qualify if:

• History of allergic reaction or hypersensitivity to vildagliptin or metformin HCl or to any of the excipients
• History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hypo-/hyperthyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hypo-/hypertension), psychiatric, neurologic (e.g. seizures), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
• Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
• History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period.
• History or evidence of type 1 diabetes mellitus or lactic ketoacidosis or diabetic ketoacidosis
• Have abnormality of glucose (FBS)
• Investigation with blood sample shows fasting blood glucose level less than 70 mg/dl or more than 99 mg/dl at screening
• History or evidence of acute pancreatitis
• History or evidence of bullous pemphigoid or exfoliative skin lesion
• History or evidence of acute pancreatitis
• History of sensitivity to heparin or heparin-induced thrombocytopenia
• History of problems with swallowing tablet or capsule
• Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
• History of diarrhea or vomiting within 24 hours prior to check-in in each period
• History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 16.12-lead ECG demonstrating QTc \>450 msec, a QRS interval \>120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject's eligibility.

Sponsors & Collaborators

• International Bio service: lead

MeSH Terms

Interventions

Vildagliptin; Metformin

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Officials

• Uthai Suvanakoot, Ph.D.Pharm

  International Bio service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thanaporn Wongyai, B.Sc.Pharm

CONTACT

024415211; thanaporn.won@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: May 23, 2024
• Primary Completion: May 25, 2024
• Study Completion: June 2, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share