Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects. (BABE)

A Single Center, Open Label, Randomized, Single-dose, Two-period, Two-way Cross-over Study to Compare the Rate and Extent of Absorption of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects.

Single oral dose of study drug in two period(s) separated by a washout period of seven (07) days. Blood samples will be taken up to 24.0 hours post-dose.

Study Overview

• Status: Completed
• Conditions: Healthy; Bioequivalence Study
• Intervention / Treatment: Drug: Dexlansoprazole; Drug: Dexlansoprazole

Detailed Description

Test Product DelanzoTMDR 60 mg Capsule, manufactured by SAMI Pharmaceuticals (Pvt.) Ltd.or Reference Product Dexilant® 60 mg Capsule, manufactured by Takeda Pharmaceutical Company Limited. will be administered to healthy male Pakistani volunteers with 240 mL ambient temperature water and blood samples will be taken up to 24 hours post dose for the calculation of Cmax, Tmax, AUC.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75270
      • Center for Bioequivalence Studies and clinical research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy subjects aged 18 to 55 years inclusive.
• Subjects with a body mass index (BMI) from 18.5 to 30 kg/m2.
• Subject is able to fast for 14 hours and consume standard meals.
• Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (i.e., blood pressure, heart rate, and temperature), 12-Lead ECG, and safety laboratory analysis (i.e., hematology, blood biochemistry, and urinalysis) or viral serology as determined by the investigator.
• Subjects should have negative urine test for drugs of abuse (morphine & cannabinoids will be tested) and alcohol breath analysis at screening and prior to each check-in.
• Subjects who are able to, understand and sign the Informed Consent Form for Medical Screening during their screening visit and Participation Informed Consent Form on study check-In day.
• Subject agreed not to consume food or beverages including tea, coffee, cola drinks, chocolates containing xanthine derivatives (including caffeine, theobromines, etc.) and/or poppy seeds (Khash khash) within 48 hours prior to drug administration until last blood draw in each study period.
• Subject agreed not to intake prescription drugs (especially any other PPI, Antiretroviral (e.g. rilpivirine, atazanavir and nelfinavir), Warfarin, clopidogrel, methotrexate, drugs dependent on gastric pH for absorption, etc.) within 14 days or 5 half-lives (whichever is longer) prior to first dose of study medicine.
• Subject agreed not to intake non-prescription drugs (OTC) within 14 days prior to first dose of study medicine.
• Subject agreed to discontinue vitamins, dietary and herbal supplements within 14 days prior to the first dose of study medication.
• Subject agreed not to consume grapefruit and/or its products within 14 days prior to the start of study.

Exclusion Criteria:

• Subjects who refused to sign Informed Consent Form.
• Inability to take oral medication.
• Pregnant and lactating females.
• History of smoking ≥3 cigarette/day, alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
• Subject has clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.
• Subjects allergic to Dexlansoprazole and/or other Antacid drugs.
• Subject has received any investigational drug within four weeks.
• Participated in any clinical trials within 3 months.
• Donation or loss of more than 450 mL of blood within 3 months prior to the screening.
• History of any significant illness in the last four weeks which might confound in the result of the study or post additional risk in administrating Dexlansoprazole to the subject.
• Subjects tested positive for syphilis (VDRL) or is known to have serum hepatitis or carrier of the Hepatitis B surface antigen (HBs Ag) or are carriers of antibodies to hepatitis C virus (anti-HCV) or to the human immunodeficiency virus (HIV-1 or HIV-2).
• Subject tested positive for COVID-19 or is known to have such family members who tested positive for COVID-19 in recent times.
• Subject has undergone any major surgery within 3 months prior to the start of the study, unless deemed eligible, otherwise by the Principal Investigator or whomever he/she may designate.
• Subject has a condition, which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or elimination of drugs.
• History of sensitivity to heparin or heparin-induced thrombocytopenia.
• History of asthma, anaphylaxis or anaphylactic reactions, severe allergic responses.
• A heart rhythm disorder (especially if you take medication to treat it) or history of long QT syndrome.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DelanzoTMDR group; Subjects will take DelanzoTMDR 60 mg Capsule, manufactured by SAMI Pharmaceuticals (Pvt.) Ltd. after at least 10 hours' fast, with 240 mL of ambient temperature water at their scheduled dosing time-point.	Drug: Dexlansoprazole; Dexlansoprazole capsule prepared by SAMI Pharmaceuticals will be administered to this arm.; Other Names: DelanzoTMDR 60 mg capsule, hard; Drug: Dexlansoprazole; Dexlansoprazole capsule prepared by Takeda Pharmaceutical Company will be administered to this arm.; Other Names: Dexilant® 60 mg capsule, hard
Active Comparator: Dexilant® Group; Subjects will take Dexilant® 60 mg Capsule, manufactured by Takeda Pharmaceutical Company Limited after at least 10 hours' fast, with 240 mL of ambient temperature water at their scheduled dosing time-point.	Drug: Dexlansoprazole; Dexlansoprazole capsule prepared by SAMI Pharmaceuticals will be administered to this arm.; Other Names: DelanzoTMDR 60 mg capsule, hard; Drug: Dexlansoprazole; Dexlansoprazole capsule prepared by Takeda Pharmaceutical Company will be administered to this arm.; Other Names: Dexilant® 60 mg capsule, hard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Determination of plasma drug concentration	24 hours
Tmax	Time to reach maximum plasma drug concentration	24 hours
AUC	Area under the Plasma concentration Versus time curve	24 hours

Collaborators and Investigators

• Sponsor: University of Karachi
• Collaborators: SAMI Pharmaceutical, Karachi Pakistan
• Investigators: Principal Investigator: Prof. Dr. Muhammad R Shah, PhD, Center for bio-equivalence, and clinical research, university of karachi; Principal Investigator: Dr. Naghma Hashmi (Co-PI), PhD, Center for bio-equivalence, and clinical research, university of karachi

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2021
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): November 25, 2022

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Bioequivalence Study, Healthy Pakistani Population,; Dexlansoprazole Capsule
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: CB-035-DEX(D)-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will only be available upon reasonable request to PI, subject to the confidentiality of the participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No