Wockhardt

Pipeline & Clinical Trials

zidebactam administered as a 1g

Healthy Subjects (HS)

Phase 1

Clinical Trials (1)

NCT07247942Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion.

Phase 1

30% Regular Insulin Human Neutral and 70%Isophane Insulin

Diabetes Mellitus

Phase 1

Clinical Trials (1)

NCT01358435Comparative Wockhardt's Glucose Clamp Study-Human Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects

Phase 1

WCK 5222

Renal Impairment

Phase 1

Clinical Trials (1)

NCT02942810To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment

Phase 1

FEP-TAZ 4 g

Antibiotics Causing Adverse Effects in Therapeutic Use

Phase 1

Clinical Trials (1)

NCT03622008To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ)

Phase 1

WCK 2349

Hepatic Impairment

Phase 1

Clinical Trials (1)

NCT02244827Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment

Phase 1

WCK 2349 Oral

Pharmacokinetics

Phase 1

Clinical Trials (1)

NCT04874324Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349

Phase 1

WCK 2349

Qt Interval, Variation in

Phase 1

Clinical Trials (1)

NCT02217930Study to Evaluate the Effect Of WCK 2349 on the QT/QTc Interval in Health Volunteers

Phase 1

3 g or 6 g Zidebactam

Healthy Subjects

Phase 1

Clinical Trials (1)

NCT02674347MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous Zidebactam in Healthy Adults

Phase 1

Wosulin R

Diabetes

Phase 1

Clinical Trials (1)

NCT00752180Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Type 1 Diabetics

Phase 1

Wosulin R

Diabetes Mellitus

Phase 1

Clinical Trials (1)

NCT00596063Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Novolin R, in Healthy Subjects.

Phase 1

Wosulin N

Diabetes

Phase 1

Clinical Trials (1)

NCT00772265Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects

Phase 1

Glargine

Type1 Diabetes

Phase 1

Clinical Trials (1)

NCT01357603Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM

Phase 1

Wosulin R

Diabetes

Phase 1

Clinical Trials (1)

NCT00719108Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Healthy Subjects.

Phase 1

Insulin Lispro

Bioequivalence in Healthy Subjects

Phase 1

Clinical Trials (1)

NCT01400789Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Listro Mix 50/50® and Humalog Mix50/50® in Healthy Subjects

Phase 1

Insulin lispro

Bioequivalence in Healthy Subjects

Phase 1

Clinical Trials (1)

NCT01399255Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Lispro (Listro™) With Humalog® in Healthy Subjects

Phase 1

Cefepime and Tazobactam combination

Renal Impairment

Phase 1

Clinical Trials (1)

NCT02709382A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment

Phase 1

Insulin Lispro

Bioequivalence in Healthy Subjects

Phase 1

Clinical Trials (1)

NCT01400802Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Mixture Listro Mix 75/25® and Humalog Mix75/25 ® in Healthy Subjects

Phase 1

WCK 5222

QT/QTc Interval in Healthy Volunteers

Phase 1

Clinical Trials (1)

NCT03554304Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers

Phase 1

WCK 5107 250 mg to 2000 mg

Healthy

Phase 1

Clinical Trials (1)

NCT02532140Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime

Phase 1

WCK 4873

Healthy

Phase 1

Clinical Trials (1)

NCT03979859Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers

Phase 1

Oral WCK2349

Effect of Food

Phase 1

Clinical Trials (1)

NCT01875939Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers

Phase 1

Nafithromycin

Healthy

Phase 1

Clinical Trials (1)

NCT03981887Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin

Phase 1

FEP-ZID

PHA1A

Phase 1

Clinical Trials (1)

NCT03630094Plasma and Intrapulmonary Concentrations Study of WCK 5222

Phase 1

WCK 4873

Healthy

Phase 1

Clinical Trials (1)

NCT02453529Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 4873 in Healthy Adult Human Subjects

Phase 1

Zidebactam-Cefepime

PHA1A

Phase 1

Clinical Trials (1)

NCT06806995A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.

Phase 1

Nafithromycin

Healthy Volunteers

Phase 1

Clinical Trials (1)

NCT02770404A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects

Phase 1

Intravenous infusions of WCK 5222

Serious Gram-negative Infections

Phase 1

Clinical Trials (1)

NCT02707107MED Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous WCK 5222 (Zidebactam and Cefepime) in Healthy Volunteers

Phase 1

WCK 4873

Healthy

Phase 1

Clinical Trials (1)

NCT03926962The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers

Phase 1

WCK-2349

Intrapulmonary Pharmacokinetics of WCK 2349

Phase 1

Clinical Trials (1)

NCT02253342Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects

Phase 1

WCK 771 IV Infusion

Bioavailability

Phase 1

Clinical Trials (1)

NCT05640531Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771

Phase 1

Nafithromycin 800 mg 3 days

Community-Acquired Bacterial Pneumonia (CABP)

Phase 2

Clinical Trials (1)

NCT02903836Phase II Study of Oral Nafithromycin in CABP

Phase 2

Oral Levonadifloxacin/Linezolid Tablet

Acute Bacterial Skin and Skin Structure Infections

Phase 3

Clinical Trials (1)

NCT03405064Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Phase 3

Cefepime-zidebactam

Complicated Urinary Tract Infection

Phase 3

Clinical Trials (1)

NCT04979806Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Phase 3

Insulin Lispro

Type I Diabetes

Phase 3

Clinical Trials (1)

NCT01398670Immunogenicity Study of Wockhardt's Insulin Lispro/Lispro Mix Basal Bolus Regimen in Type 1 Diabetics

Phase 3

WCK 4282

Complicated Urinary Tract Infection

Phase 3

Clinical Trials (1)

NCT03630081Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Phase 3

Wockhardt's Insulin Analogue

Type I Diabetes

Phase 3

Clinical Trials (1)

NCT01352663Immunogenicity Safety Study of Wockhardt's Recombinant Insulin Analogue in Type 1 Diabetic Patients

Phase 3

Wosulin

Type I Diabetes

Phase 3

Clinical Trials (1)

NCT01308437Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics

Phase 3

BUPROPION HYDROCHLORIDE

bupropion hydrochloride

Post-LOE

ORAL · TABLET, EXTENDED RELEASE

12.1 Mechanism of Action The exact mechanism of the antidepressant action of bupropion is not known but is presumed to be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine and does not inhibit the reuptake of serotonin. Bupropion does not inhibit monoamine oxidase. 12.3 Pharmacokinetics Bupropion is a racemic mixture. The pharmacological activity and pharmacokinetics of the individual enantiomers have not been studied. The mean elimination half-life (±SD) of bupropion after chronic dosing is 21 (±9) hours, and steady-state plasma concentrations of bupropion are reached within 8 days. Absorption The absolute bioavailability of bupropion hydrochloride tablets in humans has not been determined because an intravenous formulation for human use is not available. However, it appears likely that only a small proportion of any orally administered dose reaches the systemic circulation intact. In rat and dog studies, the bioavailability of bupropion ranged from 5% to 20%. In humans, following oral administration of bupropion hydrochloride tablets, peak plasma bupropion concentrations are usually achieved within 2 hours. Plasma bupropion concentrations are dose-proportional following single doses of 100 to 250 mg; however, it is not known if the proportionality between dose and plasma level is maintained in chronic use. Distribution In vitro tests show that bupropion is 84% bound to human plasma proteins at concentrations up to 200 mcg/mL. The extent of protein binding of the hydroxybupropion metabolite is similar to that for bupropion, whereas the extent of protein binding of the threohydrobupropion metabolite is about half that seen with bupropion. Metabolism Bupropion is extensively metabolized in humans. Three metabolites are active: hydroxybupropion, which is formed via hydroxylation of the tert -butyl group of bupropion, and the amino-alcohol isomers threohydrobupropion and erythrohydrobupropion, which are formed via reduction of the carbonyl group. In vitro findings suggest that CYP2B6 is the principal isoenzyme involved in the formation of hydroxybupropion, while cytochrome P450 enzymes are not involved in the formation of threohydrobupropion. Oxidation of the bupropion side chain results in the formation of a glycine conjugate of meta-chlorobenzoic acid, which is then excreted as the major urinary metabolite. The potency and toxicity of the metabolites relative to bupropion have not been fully characterized. However, it has been demonstrated in an antidepressant screening test in mice that hydroxybupropion is one-half as potent as bupropion, while threohydrobupropion and erythrohydrobupropion are 5-fold less potent than bupropion. This may be of clinical importance because the plasma concentrations of the metabolites are as high as or higher than those of bupropion. Following a single dose in humans, peak plasma concentrations of hydroxybupropion

2012

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