Dapagliflozin Tablet 10 mg Relative to Forxiga® Tablets 10 mg

NCT06233045 | Unknown Phase 1

• 1 other identifier: DAP-030-23
• Study Type: interventional
• Target: 30
• 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 fasting condition and at least 5 days washout period between the doses.

Conditions

Healthy Subjects

Keywords

Bioequivalence Dapagliflozin tablet 10 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 0.25, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00 and 48.00 hours post-dose

  Blood samples will be collected for PK analyses in each period pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00 and 48.00 hours post-dose

• Maximal measured plasma concentration (Cmax)

  pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00 and 48.00 hours post-dose

  Blood samples will be collected for PK analyses in each period pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00 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- Dapagliflozin test product and then reference product

EXPERIMENTAL

Participants will receive treatment 1 in period 1 and treatment 2 in period 2. Where treatment 1= Dapagliflozin tablet 10 mg test product, treatment 2= Dapagliflozin tablet 10 mg reference product.

Drug: Dapagliflozin-Test product

Sequence 2-Dapagliflozin reference product and then test product

EXPERIMENTAL

Participants will receive treatment 2 in period 1 and treatment 1 in period 2. Where treatment 1= Dapagliflozin tablet 10 mg test product, treatment 2= Dapagliflozin tablet 10 mg reference product.

Drug: Dapagliflozin-Reference product

Interventions

Dapagliflozin-Test product DRUG

Dapagliflozin tablet 10 mg Test product Manufactured by: ZYDUS LIFESCIENCES LIMITED, India

Sequence 1- Dapagliflozin test product and then reference product

Dapagliflozin-Reference product DRUG

Dapagliflozin tablet 10 mg Reference product Manufactured by: ASTRAZENECA PHARMACEUTICALS LP, USA

Sequence 2-Dapagliflozin reference product and then test 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 Dapagliflozin 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 or HIV.
• 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.
• Any major illness in the past 3 months or any significant ongoing chronic medical illness.
• History that may predispose to ketoacidosis including pancreatic insulin deficiency from any cause or severe starvation within 1 month before drug administration.
• 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

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: July 23, 2024
• Primary Completion: August 25, 2024
• Study Completion: September 8, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share