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

NCT04877834 | Completed Phase 1 DMC

• 1 other identifier: CB-035-DEX(D)-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Bioequivalence Study

Keywords

Bioequivalence Study, Healthy Pakistani Population,; Dexlansoprazole Capsule

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

DelanzoTMDR group

EXPERIMENTAL

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

Dexilant® Group

ACTIVE COMPARATOR

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

Interventions

Dexlansoprazole DRUG

Dexlansoprazole capsule prepared by SAMI Pharmaceuticals will be administered to this arm.

Also known as: DelanzoTMDR 60 mg capsule, hard

DelanzoTMDR group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Healthy Pakistani Population
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Karachi: lead
• SAMI Pharmaceuticals (Pvt.) Ltd.: collaborator

Study Sites (1)

Center for Bioequivalence Studies and clinical research

Karachi, Sindh, 75270, Pakistan

Location

MeSH Terms

Interventions

Dexlansoprazole; Capsules; Hardness

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations; Mechanical Phenomena; Physical Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A single center, open-label, randomized, single-dose, two-period, two-way, cross-over study.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 7, 2021
• Study Start: September 18, 2021
• Primary Completion: October 25, 2022
• Study Completion: November 25, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)