Clinical trials: Therapeutic Equivalency
Healthy Subjects
Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers
The study was designed as a single-site, randomized, open-label, four-period complete and replicate crossover. A single oral dose of 20 mg rivaroxaban tablet (test) and Xarelto®(reference) was given to the 72 healthy Chinese…
- Trial name
- NCT04424381
- Testing
- Rivaroxaban 20 MG Oral Tablet [Xarelto], Rivaroxaban 20 MG Oral Tablet
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Healthy
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 300 μg tablets to Lloyd's Levothroid® 300 μg tablets following a single 600 μg (2 x 300 μg) dose administered in healthy adult…
- Trial name
- NCT00648700
- Testing
- Levothyroxine Sodium Tablets 300 μg, Levothroid® Tablets 300 μg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Diabetes, Healthy
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Subjects
This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male subjects.
- Trial name
- NCT01527643
- Testing
- biphasic insulin aspart 50
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy
Bioequivalence Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fasting Conditions
To compare the single-dose oral bioavailability of clarithromycin 250-mg/5 mL powder for oral suspension of Ranbaxy Laboratories with that of Abbott Laboratories (Biaxin®) following administration of a 250 mg/5 mL dose in…
- Trial name
- NCT00775255
- Testing
- clarithromycin 250 mg/5 mL powder for oral suspension
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Seasonal Allergic Rhinitis
Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients
This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray, 50 mcg (Teva Pharmaceuticals USA) to the…
- Trial name
- NCT02246920
- Testing
- Fluticasone propionate, Flonase®
- Where
- United States
- Volunteers
- 1,474 people
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Levetiracetam 750 mg Tablets Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of a test formulation of Levetiracetam and the reference Keppra® administered as a 1 x 750 mg tablet under fasting conditions.
- Trial name
- NCT00849862
- Testing
- Levetiracetam, Keppra®
- Where
- Canada
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Comparison of Bioavailability of Dexketoprofen-Vit B vs Dexketoprofen, in Healthy Subjects, Under Fasting Conditions
Bioavailability comparison study with a cross-over desing, 2x2, open, prospective and longitudinal, at a single dose with two treatments, two periods, two sequences with an elimination (washout) period of 7 days and a number of…
- Trial name
- NCT05027126
- Testing
- Dexketoprofen 25 MG, Fixed dose Dexketoprofen-Vitamin B Complex
- Where
- Mexico
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Laboratorios Silanes S.A. de C.V.
Healthy
To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fed state.
- Trial name
- NCT01101178
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Healthy Volunteers
Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fasting Condition
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus)…
- Trial name
- NCT01080482
- Testing
- Tacrolimus 5 mg Capsule
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Clinical Pharmacology
Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet
The primary objective of this study was to establish the bioequivalence of two different tablet formulations containing BAY77-1931.
- Trial name
- NCT03074058
- Testing
- Fosrenol ODT (Lanthanum Carbonate, BAY77-1931), Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)
- Where
- Japan
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bayer
Infections, Bacterial
Bioequivalence Study Between GR37547 500 Milligrams (mg) Tablet Versus Ciprofloxacin 500 mg Tablet Reference Product in Healthy Adult Subjects
This two-period cross-over study will evaluate bioequivalence of GR37547 (ciprofloxacin 500 mg) tablet versus ciprofloxacin 500 mg reference tablet in healthy adult subjects under fasting conditions.
- Trial name
- NCT03150082
- Testing
- GR37547 tablet, Ciprofloxacin reference tablet
- Where
- South Africa
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
GXR RM China BE Study (Darmstadt - Jiangsu)
The purpose of this study is to assess Bioequivalence (BE), pharmacokinetics (PK), safety and tolerability following single oral dose administrations between a Glucophage Extended Release, Reduced Mass (Glucophage XR RM)…
- Trial name
- NCT05463094
- Testing
- Test Glucophage® XR, Reference Glucophage® XR
- Where
- Germany
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy
Clinical Bioequivalence Study on Two Lisinopril Tablets 20mg Formulations
The objective of the study is to compare the bioavailability of a generic product of lisinopril with that of a reference product when administered to healthy volunteers under fasting condition.
- Trial name
- NCT03599466
- Testing
- BF-Lisinopril Tablets 20mg, Zestril Tab 20mg
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Healthy
Food Study of Sertraline Hydrochloride Tablets 100 mg and Zoloft® Tablets 100 mg
The objective of this study was to investigate the bioequivalence of Mylan's sertraline hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administration under fed…
- Trial name
- NCT00648856
- Testing
- Sertraline Hydrochloride Tablets 100 mg, Zoloft® Tablets 100 mg
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Diabetes, Healthy
A Comparison Between Two Formulations of NN5401 in Healthy Subjects
This trial is conducted in the United States of America (USA). The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in healthy subjects.
- Trial name
- NCT01125553
- Testing
- insulin degludec/insulin aspart
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy
Trandolapril 4 mg Tablet Under Non-Fasting Conditions
The objective of this study is to evaluate the comparative bioavailability between trandolapril 4 mg tablets (test) and Mavik® 4 mg Tablets (reference) after a single-dose in healthy subjects under fed conditions.
- Trial name
- NCT00840073
- Testing
- Trandolapril 4 mg Tablets, Mavik® 4 mg Tablets
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.
The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and…
- Trial name
- NCT02084056
- Testing
- Linagliptin, Metformin, Linagliptin/Metformin FDC
- Where
- Germany
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use
To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in…
- Trial name
- NCT01344629
- Testing
- Telmisartan/Amlodipin FDC, Telmisartan, Amlodipin
- Where
- Japan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Infections, Respiratory Tract
A Bioequivalence Study of an Acetylcysteine 2% Oral Solution Versus a Reference Fluimucil 2% Oral Solution
This is an open-label, randomized, single-center, 2-period, 2-sequence, single-dose crossover design study in adult male and female healthy participants.
- Trial name
- NCT02688361
- Testing
- Fluimucil® 2% solution, Acetylcysteine 2% solution
- Where
- Germany
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions
The purpose of this study is to evaluate the single-dose Pharmacokinetic (PK) and bioequivalence of darunavir (DRV) in the presence of cobicistat (COBI) when administered as a scored fixed dose combination (FDC) tablet (DRV/COBI)…
- Trial name
- NCT04718805
- Testing
- Darunavir, Cobicistat, Darunavir/Cobicistat FDC
- Where
- Belgium
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
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