Bioequivalence Study Between Capoten Versus Captopril Reference Product in Healthy Adult Participants Under Fasting Conditions

NCT04878315 | Withdrawn Phase 1

• 1 other identifier: 213048
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a bioequivalence study to compare Capoten (test product \[T\]) versus captopril (reference product \[R\]) produced by Mylan Pharmaceuticals Spain, in healthy adult participants under fasting condition. Capoten is the registered trademark of SmithKline Beecham Egypt.

Conditions

Healthy Volunteers

Keywords

Bioequivalence; Capoten; Captopril; Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum observed concentration (Cmax) of Captopril

  Up to 3 weeks

• Area under the concentration-time curve from administration extrapolated to the last time of quantifiable concentration (AUC[0-t]) of Captopril

  Up to 3 weeks

• Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of Captopril

  Up to 3 weeks

Secondary Outcomes (7)

• Time to reach Cmax (Tmax) of Captopril

  Up to 3 weeks

• Terminal elimination halftime (t1/2) of Captopril

  Up to 3 weeks

• Terminal elimination rate constant (lambda-z) of Captopril

  Up to 3 weeks

• Percentage of AUC(0-inf) obtained by extrapolation (%AUCex) of Captopril

  Up to 3 weeks

• Number of participants reporting adverse events (AEs)

  Up to 3 weeks

Study Arms (3)

Treatment sequence TRR

EXPERIMENTAL

Participants will receive Capoten (T) in period 1 followed by Captopril (R) in period 2 followed by Captopril (R) in period 3.

Drug: Capoten; Drug: Captopril

Treatment sequence RTR

EXPERIMENTAL

Participants will receive Captopril (R) in period 1 followed by Capoten (T) in period 2 followed by Captopril (R) in period 3.

Drug: Capoten; Drug: Captopril

Treatment sequence RRT

EXPERIMENTAL

Participants will receive Captopril (R) in period 1 followed by Captopril (R) in period 2 followed by Capoten (T) in period 3.

Drug: Capoten; Drug: Captopril

Interventions

Capoten DRUG

Capoten will be administered per the treatment sequence

Treatment sequence RRT; Treatment sequence RTR; Treatment sequence TRR

Captopril DRUG

Captopril will be administered per the treatment sequence

Treatment sequence RRT; Treatment sequence RTR; Treatment sequence TRR

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 50 years of age inclusive
• Participant does not have a known allergy to the drug under investigation, any of its ingredients or any other related drugs.
• Normal vital signs after up to 10 minutes resting in supine position or 2 minutes in sitting position: 100 millimeter of mercury (mmHg) =\< systolic blood pressure (SBP) \<130 mmHg; 70 mmHg =\< diastolic blood pressure (DBP) \<90 mmHg; 60 beats per minute (bpm) =\< Pulse rate (HR) =\< 100 bpm.
• Normal standard 12-lead ECG after 10 minutes resting in supine position in the following ranges; 120 milliseconds (ms)\<PR\<220 ms, QRS\<120 ms, corrected QT interval (QTc)=\<450 ms, and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
• Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for healthy participants; however serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) should not exceed 1.25 times the upper laboratory norm, and total bilirubin should not exceed the upper laboratory normal (Laboratory tests are performed not longer than two weeks before the initiation of the clinical study).
• Body weight on 45 kilogram (kg) or more and body mass index (BMI) within the range 18.5-30 kilogram per meter square (kg/m\^2) (inclusive).
• Capable of giving signed informed consent as described in the protocol.

You may not qualify if:

• Any history or presence of clinically relevant cardiovascular including history of hypotension and orthostatic hypotension, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular or infectious disease, or signs of acute illness, lactose intolerance.
• Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
• Blood donation, any volume, within 2 months.
• Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure \>=30 mmHg within 3 minutes when changing from supine to standing position.
• Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Participants with known hypersensitivity to any component of the investigational medicinal product (IMP) formulation or allergic disease diagnosed and treated by a physician.
• History of drug or alcohol abuse. History of regular alcohol consumption within one year of the study defined as: an average weekly intake of \>14 drinks. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 milliliter \[mL\]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
• Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled). Excessive consumption of beverages containing xanthine bases \[more than 4 cups or glasses (average 100 mL) per day\].
• Use of any prescribed medication, over the counter (OTC) medicines or medicinal products during the last two weeks preceding the first dosing and until discharge from the study.
• Participation in a bioequivalence study or in a clinical study within the last 60 days (2 months) before first study drug administration.
• Positive result on any of the following tests: hepatitis B surface antigen (HBsAg), anti-hepatitis B core antibodies (anti-HBc Ab) if compound having possible immune activities, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
• Positive result on urine drug screen (amphetamines/ methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
• Participant who has results of laboratory tests which are outside the normal range or hemoglobin (Hb) or red blood cells (RBC) indices (mean corpuscular volume \[MCV\], mean corpuscular hemoglobin \[MCH\] and mean corpuscular hemoglobin concentration \[MCHC\]) with deviation outside 5% of the reference range at screening. (Laboratory tests are performed not longer than two weeks before the initiation of the clinical study).
• Participants who have been on a specific/special diet during the 4 weeks before screening and who cannot agree to eat the set clinical food menu during the study.
• Difficulty in swallowing tablets.
• Participants that have a current active Coronavirus disease 2019 (COVID-19) infection, either laboratory confirmed or according to the investigator's medical judgement.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Interventions

Captopril

Intervention Hierarchy (Ancestors)

Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is an open-label study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a 3-period, 2-treatment, 3-sequence, partially replicated crossover study

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: February 13, 2022
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.