Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Relative to Originator

NCT06233201 | Unknown Phase 1

• 1 other identifier: SME-033-23
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fed condition and at least 7 days washout period between the doses.

Conditions

Healthy Subjects

Keywords

Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t)

  pre-dose (0.00 hour) and at 0.333, 0.667, 1.000, 1.500, 2.000, 2.500, 3.000, 3.333, 3.667, 4.000, 4.333, 4.667, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 24.00, 36.00 and 48.00 hours post-dose

  Blood samples will be collected for PK analyses in pre-dose and at 0.333, 0.667, 1.000, 1.500, 2.000, 2.500, 3.000, 3.333, 3.667, 4.000, 4.333, 4.667, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 24.00, 36.00 and 48.00 hours post-dose

• Maximal measured plasma concentration (Cmax)

  pre-dose (0.00 hour) and at 0.333, 0.667, 1.000, 1.500, 2.000, 2.500, 3.000, 3.333, 3.667, 4.000, 4.333, 4.667, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 24.00, 36.00 and 48.00 hours post-dose

  Blood samples will be collected for PK analyses pre-dose (0.00 hour) and at 0.333, 0.667, 1.000, 1.500, 2.000, 2.500, 3.000, 3.333, 3.667, 4.000, 4.333, 4.667, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 24.00, 36.00 and 48.00 hours post-dose

Secondary Outcomes (1)

• Number of subjects with adverse events

  Approximately the day 14 after the last visit

Study Arms (2)

Sequence 1-Sitagliptin and Metformin Hydrochloride Tablets test product

EXPERIMENTAL

Participants will receive treatment 1 in period 1 and treatment 2 in period 2. Where treatment 1= Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg test product, treatment 2= Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg reference product.

Drug: Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Test product

Sequence 2-Sitagliptin and Metformin Hydrochloride Tablets reference product

EXPERIMENTAL

Participants will receive treatment 2 in period 1 and treatment 1 in period 2. Where treatment 1= Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg test product, treatment 2= Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg reference product.

Drug: Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Reference product

Interventions

Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Test product DRUG

Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Manufactured by: Mankind Pharma Limited, India

Sequence 1-Sitagliptin and Metformin Hydrochloride Tablets test product

Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Reference product DRUG

Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Manufactured by: Patheon Puerto Rico, Puerto Rico 00674

Sequence 2-Sitagliptin and Metformin Hydrochloride Tablets reference product

Eligibility Criteria

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

You may qualify if:

• Willingness to provide written informed consent prior to participate in the study.
• Healthy Thai subjects are between 18 to 55 years of age.
• The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2.
• Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects' safety after the completion of the study.
• Negative urine pregnancy test for women and no breast-feeding.
• Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician.

You may not qualify if:

• History or evidence of allergy or hypersensitivity to Sitagliptin, Metformin or any related drugs or any of the excipients of this product.
• Subject with B.P. is Systolic B.P \< 90, ≥140 mm/Hg, Diastolic B.P \< 60, ≥90 mm/Hg, pulse rate \> 100 beats per minute.
• Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).\*
• Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).\*
• Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).\*
• Positive of hepatitis B or C virus.
• Have more than one abnormal EKG, which is considered as clinically significant. \*
• History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension or glaucoma
• History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy.
• History or evidence of hypoglycemia before drug administration of each period.\*
• Any major illness in the past 3 months or any significant ongoing chronic medical illness.
• History of psychiatric disorder.
• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
• History of usually smoking (more than 10 cigarettes per day within past 1 year), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of the study.
• High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.

Sponsors & Collaborators

• Bio-innova Co., Ltd: lead

MeSH Terms

Interventions

Sitagliptin Phosphate; Metformin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Sasitorn Kittivoravitkul, Ph.D.

CONTACT

022549008; sasitorn_k@bio-innova.com

Somkiat Tatritorn, M.D.

CONTACT

022549008; somkiat_t@bio-innova.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 31, 2024
• Study Start: June 4, 2024
• Primary Completion: July 14, 2024
• Study Completion: July 28, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share