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Pantoprazole Sodium Sesquihydrate

This article explores the use of Pantoprazole Sodium Sesquihydrate in clinical trials, focusing on bioequivalence and bioavailability studies. These studies compare different formulations of pantoprazole, sometimes in combination with acetylsalicylic acid (ASA), under various conditions. The trials aim to assess how well generic versions of the drug compare to brand-name versions, and how food intake affects drug absorption. Understanding these aspects is crucial for ensuring the effectiveness and safety of pantoprazole in treating conditions such as ulcers and acid reflux.

Table of Contents

What is Pantoprazole?

Pantoprazole Sodium Sesquihydrate, commonly known as pantoprazole, is a medication used to treat various gastrointestinal conditions. It belongs to a class of drugs called proton pump inhibitors (PPIs), which work by reducing stomach acid production[1]. Pantoprazole is available under different brand names, including Protonix® and Protium®[4].

Uses of Pantoprazole

Pantoprazole is primarily used to treat the following conditions:

  • Gastric and duodenal ulcers: These are sores that develop in the lining of the stomach or the first part of the small intestine (duodenum)[3].
  • Gastroesophageal reflux disease (GERD): A condition where stomach acid frequently flows back into the esophagus, causing heartburn and other symptoms.
  • Erosive esophagitis: Inflammation and damage to the esophagus caused by stomach acid.
  • Zollinger-Ellison syndrome: A rare condition that causes tumors in the pancreas or duodenum, leading to excessive stomach acid production.

Available Formulations

Pantoprazole is available in various formulations, including:

  • Delayed-release tablets: These tablets are designed to release the medication in the small intestine rather than the stomach, ensuring better absorption and effectiveness. They are available in 20 mg and 40 mg strengths[1].
  • Gastro-resistant tablets: Similar to delayed-release tablets, these are designed to resist stomach acid and release the medication in the intestine[4].
  • Fixed-dose combination capsules: In some cases, pantoprazole is combined with other medications, such as acetylsalicylic acid (ASA), in a single capsule for convenient administration[3].

How Pantoprazole Works

Pantoprazole works by blocking the proton pumps in the stomach lining. These pumps are responsible for producing stomach acid. By inhibiting these pumps, pantoprazole reduces the amount of acid produced in the stomach, which helps alleviate symptoms and promote healing of damaged tissues in the digestive tract[1].

Dosage and Administration

The dosage of pantoprazole varies depending on the condition being treated and the specific formulation used. Some general guidelines include:

  • For most conditions, a common dose is 40 mg once daily[1].
  • In some cases, lower doses of 20 mg may be used, especially for maintenance therapy[3].
  • Pantoprazole is typically taken orally with or without food, depending on the specific formulation and instructions provided by your healthcare provider.
  • It’s important to take pantoprazole exactly as prescribed and not to adjust the dose without consulting your doctor.

Bioequivalence Studies

Several studies have been conducted to compare different formulations of pantoprazole and ensure they are bioequivalent (meaning they have the same effect in the body). These studies help ensure that generic versions of the medication are as effective as brand-name versions. Key findings from these studies include:

  • Comparisons between different manufacturers’ versions of pantoprazole 40 mg delayed-release tablets showed similar effectiveness[1].
  • Studies were conducted under both fasting and fed conditions to ensure the medication works effectively regardless of when it’s taken in relation to meals[2][4].
  • Fixed-dose combination capsules containing pantoprazole and acetylsalicylic acid (ASA) were also studied to ensure proper absorption of both medications when taken together[3].

Potential Side Effects and Tolerability

While pantoprazole is generally well-tolerated, like all medications, it can cause side effects in some people. Common side effects may include:

  • Headache
  • Nausea
  • Diarrhea
  • Stomach pain
  • Dizziness

Studies have been conducted to assess the tolerability of pantoprazole, including when combined with other medications like ASA. These studies monitored for adverse events, conducted laboratory tests, and checked vital signs and electrocardiograms (ECGs) to ensure the medication’s safety[4].

It’s important to discuss any side effects or concerns with your healthcare provider. They can provide personalized advice and determine if pantoprazole is the right medication for your specific condition.

Aspect Details
Study Types Bioequivalence and bioavailability studies
Drug Formulations Pantoprazole Sodium Sesquihydrate (40 mg), Fixed-dose combination of ASA (100 mg) and Pantoprazole (20 mg)
Study Conditions Fasting and fed states
Study Design Open-label, randomized, crossover studies
Primary Outcomes Pharmacokinetic parameters (Cmax, Tmax, AUC, half-life)
Secondary Outcomes Tolerability assessment (adverse events, lab tests, vital signs, ECG)
Comparisons Generic formulations vs. brand-name products (e.g., Protonix, Protium)
Target Conditions Ulcers (duodenal and gastric), acid-related disorders

FAQ

  • What is the purpose of bioequivalence studies for Pantoprazole Sodium Sesquihydrate? Bioequivalence studies aim to compare generic versions of Pantoprazole Sodium Sesquihydrate with brand-name versions to ensure they have similar effectiveness and safety profiles. This helps establish that generic formulations can be used interchangeably with brand-name drugs.
  • How do fasting and fed conditions affect these studies? Studies are conducted under both fasting and fed conditions to understand how food intake affects drug absorption. In fasting studies, participants fast overnight before taking the drug, while in fed studies, they consume a high-calorie, high-fat meal before dosing. This helps determine if food significantly impacts the drug's effectiveness.
  • What is a fixed-dose combination capsule in these trials? A fixed-dose combination capsule in these trials contains two drugs in one capsule – Acetylsalicylic Acid (ASA) and Pantoprazole. For example, some studies tested capsules containing 100 mg of ASA and 20 mg of Pantoprazole. This combination is being studied for its potential benefits in treating certain conditions.
  • What are the main outcomes measured in these clinical trials? The main outcomes measured are pharmacokinetic parameters. These include maximum plasma concentration (Cmax), time to reach maximum concentration (Tmax), area under the plasma concentration-time curve (AUC), and half-life of the drug. These measurements help determine how the body processes the drug.
  • How is the tolerability of Pantoprazole assessed in these studies? Tolerability is assessed by monitoring adverse events, conducting laboratory tests, checking vital signs, and performing electrocardiograms (ECGs) on the participants. This helps ensure the safety of the drug formulations being tested.

Ongoing Clinical Trials on Pantoprazole Sodium Sesquihydrate

  • Celecoxib versus placebo for pain and quality of life in adult patients with chronic pancreatitis

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on the Effects and Safety of Pantoprazole for Children and Teens with Healed Erosive Esophagitis

    Not recruiting

    2 1
    Investigated drugs:
    Belgium Slovakia

Glossary

  • Bioequivalence: A state where two drugs with the same active ingredient have essentially the same rate and extent of absorption when given in the same dose under similar conditions.
  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and is able to have an active effect.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Cmax: The maximum concentration of a drug in the blood after it has been administered.
  • Tmax: The time it takes for a drug to reach its maximum concentration in the blood.
  • AUC (Area Under the Curve): A measure of the total exposure to a drug over time, used to assess the extent of drug absorption.
  • Half-life: The time it takes for the concentration of a drug in the body to be reduced by half.
  • Delayed Release: A type of drug formulation designed to release the active ingredient later after ingestion, often used to protect the drug from stomach acid.
  • Gastro-resistant: A type of tablet coating that prevents the drug from being released in the stomach, allowing it to pass into the intestines before dissolving.
  • Fixed Dose Combination: A single pill or capsule that contains two or more active pharmaceutical ingredients.
  • Washout period: A period of time during a clinical trial when participants do not receive any treatment, allowing the effects of a previous treatment to wear off before starting a new one.
  • Crossover study: A type of clinical trial where participants receive different treatments in a specific order, with each participant serving as their own control.

References

  1. https://clinicaltrials.gov/study/NCT01654705
  2. https://clinicaltrials.gov/study/NCT01654718
  3. https://clinicaltrials.gov/study/NCT01847417
  4. https://clinicaltrials.gov/study/NCT01847404